Running head: CHAPTER 1
1
IV acetaminophen Research Proposal Chapter 1
Cathy Bozek, Karen Collins, Beth Kalkman, Lori Van Zoeren, and Joel Vedders
Ferris State University
Running head: CHAPTER 2
2
Research Proposal Introduction
The side effects of opioids and their use in postoperative patients are well documented.
These side effects include sedation, nausea, vomiting, respiratory depression, and constipation
(Memis, Inal, Kavalci, Sezer, & Sut, 2010). Pain control in the elderly hip fracture population
(defined as adults sixty-five years and older) often requires the use of opioids to assist in
postoperative pain control. Administration of opioids can lead to the unwanted side effects
previously listed. However, under-treatment of pain in this population can also have detrimental
effects on the patient's recovery. “Cognitively intact patients with undertreated pain were nine
times more likely to develop delirium than patients whose pain was adequately treated"
(Morrison et al., 2003, p. 80).
Patient outcomes can also be affected when pain is under-treated. These include
increased length of hospital stay, missed or shortened therapy sessions, decreased likelihood of
ambulating by the third postoperative day, and decreased ambulation scores six months after
surgery (Morrison et al., 2003). The goal is to strike a balance between minimizing opioid side
effects and maximizing patient outcomes. A multimodal approach to pain control has been
shown to be effective in the reduction of opioid consumption (Morrison et al., 2003). This
method often adds the use of non-opioid medications as an adjunct with the goal of reducing the
amount of opioids needed for optimal pain control. A non-opioid that has been recently
approved for use in the United States is intravenous (IV) acetaminophen. Several studies have
been performed using IV acetaminophen showing favorable results in its effectiveness in
reducing the amount of opioids used postoperatively. Limited data is available specifically
related to its use in the elderly hip fracture population and comparison studies between IV and
oral acetaminophen administration. On the basis of this limited data it is therefore necessary to
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verify our hypothesis comparing the efficacy of IV acetaminophen versus oral administration in
the elderly hip fracture population for optimal pain control and reduced consumption of opioids.
As nurse educators utilizing evidence-based practice and research is essential in
providing quality care. It is imperative that we understand the rationale for providing
multimodal pain management for the elderly hip fracture population. Therefore research that
furthers our understanding of pain management will enhance not only practice at the beside but
broadens our knowledge of pain management as a whole.
Abbreviated Literature Review
IV acetaminophen was approved for use in the United States by the Food and Drug
Administration (FDA) in 2010 (Smith, 2011). The initial use was limited to acute pain and fever
in pediatric and adult populations (Marcario and Royal, 2010). Prior to FDA approval, a
prospective randomized study performed in Sweden by Pettersson, Jakobsson, and Owall (2005)
examined the opioid sparing effect of IV paracetamol (acetaminophen) administration compared
to that of oral acetaminophen administration in coronary bypass patients. According to their
findings, opioid sparing was somewhat improved in the IV administered group, but not
significantly so, and adverse effects (nausea and vomiting) were similar in both study groups
during the post-operative period. The same year, in a multi-center, double-blinded, placebocontrolled, repeated-dose, 3 parallel-group study, Yale researchers demonstrated the safety and
efficacy of IV acetaminophen in comparison to propacetamol (a precursor to
paracetamol available in Europe for over 20 years) for pain management in orthopedic patients
(Sinatra et al., 2005).
A double-blind randomized controlled trial presented in New Zealand in 2009 by Brett,
Barnett, and Pearson (2012), verified a more rapid achievement of elevated plasma levels of
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acetaminophen through intravenous administration when compared to the oral route in postoperative patients. The rapid onset of higher plasma levels, they hypothesized, insured quicker
onset of a therapeutic range of acetaminophen and therefore, decreased the need for rescue
analgesia during the early recovery period for IV recipients. Although statistically significant
differences were not demonstrated between oral and IV routes, a trend towards a reduced need
for rescue analgesia in the IV route was confirmed in knee arthroscopy patients (Brett, Barnett,
& Pearson, 2012).
Memis, Inal, Kavalci, Sezer, and Sut (2010) studied the efficacy of IV acetaminophen in
reducing opioid use, decreasing opioid related adverse effects, and decreasing time to extubation
for post-operative patients in the intensive care unit. In this Turkish study, initially presented as
a poster presentation in 2009 at the European Society of Intensive Care Medicine Congress, IV
acetaminophen was used as a complement to Demerol administration for the management of
post-operative pain. Results of the study confirmed improved pain control, decreased Demerol
usage, and reduced nausea, vomiting, and sedation through the combined therapy of IV
acetaminophen and Demerol.
A literature review was presented by Marcario and Royal (2010) providing a summary of
studies conducted worldwide related to the analgesic effects of IV acetaminophen. The study
included information related to propacetamol a precursor to the current, paracetamol formulation
in comparison to placebo or active comparator. Their description of 16 studies completed in 9
countries, supports IV acetaminophen as an effective postoperative analgesic.
As part of the New Drug Application (NDA), Sinatra, et. al (2011) validated the findings
of their 2005 study providing more quantifiable data. This data included:
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pain intensity differences over 24 hours using currently accepted imputation
methods . . ., efficacy after the first 6 hours, effects of gender,
race/ethnicity, age, weight, surgical site, American Society of Anesthesiologist
(ASA) class, and serotonin antagonists; and a stepwise regression analysis of why
adverse event of nausea and vomiting were numerically (although not
statistically) higher in the IV acetaminophen group compared with placebo
(p. 357).
Findings of this study confirmed the researchers' earlier results verifying IV acetaminophen as a
safe and effective analgesic agent.
Most recently, Jahr, Breitmeyer, Pan, Royal, and Ang (2012) presented data from three
randomized trials on the efficacy and safety of IV acetaminophen use in the elderly orthopedic
post-surgical patients. Using subjects meeting inclusion criteria for their purposes, the
researchers extracted information from existing studies on IV acetaminophen to discuss its use in
light of the unique complications and co-morbidities of this population when experiencing hip or
knee replacement. The author's findings promote IV acetaminophen as a desirable alternative to,
or compliment of, opioid pain relief.
Problem/Purpose Statement
Many studies have been performed using IV acetaminophen in a multimodal approach to
pain post-operatively. Until recently, however, little data was available about IV acetaminophen
use in the elderly hip fracture population. Jahr et al. (2012) compared the efficacy and safety of
IV acetaminophen in the elderly following orthopedic surgery. Nevertheless, there is limited
information regarding the appropriate length of time IV acetaminophen should be used or the
effectiveness of IV versus oral administration of acetaminophen in controlling pain.
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As the aging population increases, the incidence of hip fracture will also increase.
According to Chang, Center, Nguyen, and Eisman (2004), the incidence of hip fracture is
predicted to be 2.6 million by 2025 and reach 4.6 million by 2050. In 2006 the Center for
Disease Control (CDC) reported that of the 900,000 discharges from short stay hospitals,
566,000 were the result of fractures in those age 65 or older (Jahr, Breitmeyer, Pan, Royal, &
Ang, 2012). Hip fractures are one of the most costly fractures that nurses see in practice (Chang,
et al., 2004). Failure to provide adequate pain control, while minimizing side effects related to
opioid use, will result in increased healthcare costs related to lengthened hospital stays. It is
therefore essential that this population receives optimal and efficient care. This is particularly
important to nursing practice as awareness and education is needed related to all the potential
complications that elderly hip fracture patients face, especially pain. A potential solution to
providing adequate pain relief in this population may lie in a multimodal approach using IV
acetaminophen in conjunction with opioids.
The knowledge gap that exists with regard to the use of IV acetaminophen in the hip
fracture population, as well as gaps in efficacy over time comparing IV and oral administration
demonstrates the need to pursue this information. Considering the expected explosion in elderly
hip fractures over the coming years, this information will be very useful as we strive for optimal
outcomes for this population. Therefore based on this preliminary examination of IV
acetaminophen and the needs of elderly hip fracture patients, this group hypothesized: Elderly
hip fracture patients (ages 65 and older) who receive IV acetaminophen for 48 hours postoperatively use less rescue opioids than those who receive scheduled oral acetaminophen for 48
hours following surgery. This purpose statement may yield vital information to fill gaps in
current available research.
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Theoretical Framework
The relationship between theory and research is reciprocal (Polit & Beck, 2012). Nursing
theories provide structure and offer a systematic approach to research (Cody, 2013). A
theoretical framework can be utilized by both quantitative and qualitative research. In the
assessment of any proposed research, basic questions need to be asked of the study’s chosen
framework. These questions include: Is the theory clear, too simple or too complex, grounded in
reality, appropriate, and important (Polit & Beck, 2012). Additional questions to be asked are,
has the theory been utilized with prior research, and is the theory credible (Polit & Beck, 2012).
A theory gains credibility through evidence which lends support to a theory’s previously
accepted tenet (or conversely, weakened by evidence to the contrary). It is important to ensure a
“fit” between the theory chosen and the research.
As the research problem states, in the growing elderly population there is an increased
incidence of hip fractures requiring surgical repair (Chang, Center, Nguyen, and Eisman, 2004).
Maintaining adequate postoperative pain control for these patients can be difficult. The elderly
often have other co morbidities and are affected differently than younger adults with the use of
opioids. Appropriate postoperative pain management is essential to the positive outcome of the
elderly surgical patient. The authors have chosen to conduct research to determine if IV
acetaminophen is more effective than oral acetaminophen in the elderly postsurgical hip fracture
patient, specifically to reduce the side effects caused by opioid use.
Several theories regarding pain exist. Many theoretical frameworks were considered to
guide this research proposal. Lenz and Pugh’s (1997) theory of unpleasant symptoms was one
theory considered. This theory explains the catalytic behavior between two or more symptoms
occurring at the same time, thus making the patient’s perception of each symptom more intense.
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Another theory considered was Auvil-Novak’s (1997) middle-range theory of chronotherapeutic
intervention for postsurgical pain. This theory explores the concept of circadian rhythm pain.
Since the authors are trying to support the use of IV acetaminophen in striking a balance between
analgesia and side effects, Good’s theory Pain: A balance between analgesia and side effects
theory was chosen. This theory contains three propositions which are multimodal intervention,
attentive care, and patient participation. Good’s (2009) theory makes five assumptions which
include:

providers will interact with nursing to manage acute pain

opioid analgesic are indicated

medication is given for side effects as needed

patients have set goals, have the ability to learn, and can communicate symptoms

Nurses have knowledge of pain management.
Assessment of the Model
Theoretical clarity: Good’s theory clearly defines outcomes and propositional statements.
Theoretical and operational definitions are listed. Basic assumptions are consistent with one
another.
Theoretical complexity: This theory is comprised of three outcomes; 1) Balance
between analgesia and side effects, 2) Pain, and 3) Side effects. Proposition one encompasses
potent pain medication (opioid) use, and a pharmacologic adjunctive (IV acetaminophen), and
non-pharmacologic interventions (nursing therapies-i.e. early ambulation, coughing, and deep
breathing). Proposition two discusses the regular assessment of pain and side effects (giving
regular scheduled doses of IV acetaminophen for 48 hours postoperatively), identification of
pain relief (numeric scale), and reassessment and/or further nursing interventions. Proposition
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three is concerned with patient education and goal setting that is mutually agreed upon by the
patient and the healthcare team.
Theoretical grounding: When discussing theoretical grounding, Polit and Beck (2012)
ask the question “are the concepts identifiable in reality” (p.138). Good’s (2009) Pain theory is
easily identified in studies. Two studies were offered in the research.
Appropriateness of the theory: The theory is fairly narrow so researchers can utilize
minimal randomization control trials (RCTs) in the adult population suffering from postoperative
hip surgery pain.
Importance: The goal of this theory was to provide a more holistic approach to pain
management. Utilization of multimodal entities allows for decreased opioid use.
General issues: A limitation of this theory is that it does not express the treatment of
pain in the elderly population.
Nursing models and theories represent ideal, logical, unique perspectives or “maps” of
the person and health (Cody, p. 339). The following three questions will help the nurse identify
the most appropriate model.

Does the theory or model address the client’s problems and health concerns?

Are the nursing interventions suggested by the model consistent with the client’s
expectations for nursing care?

Are the goals of nursing actions, based on the model or theory, congruent with the
client’s desired health outcomes (Cody, p. 345)?
A concept map is attached as an appendix. This map is a visual representation of the
proposed research within this theoretical framework. It is the assumption of this group that IV
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acetaminophen use in the elderly post operative hip fracture patients will elicit decreased opioid
use and side effects compared to oral acetaminophen use.
Research Questions
Research questions seek to address a research problem, and also the strength and
direction of the variables as they relate to each other (Polit & Beck, 2012). When considering a
research question for a proposed project it is important to think in terms of variables.
Determining the exact variables of focus will clarify the researchable questions (Polit & Beck,
2012).
Utilizing evidenced-based practice and research ensures nurses provide optimal care to
this patient population. With the projected rise in the elderly hip fracture population it is
imperative that nurses will be actively involved in research which will improve patient outcomes.
The use of IV acetaminophen as an analgesic, with fewer side effects than other analgesics,
provides the safest option for pain management (Vadivelu, Mitra, and Narayan, 2010).
This study is well suited to produce quantitative data. Quantitative research questions
produce information that can be measured. There are three levels of research questions that must
be considered. A level one statement is used when you have limited research on a issue or topic.
A level 2 purpose statement addresses what you will observe, but are unable to predict what you
will find (Wood & Ross-Kerr, 2011). A level III purpose statement is written as a hypothesis or
also known as a predictive hypothesis where you assume a relationship between your variables
(Wood & Ross-Kerr, 2011). Due to what is currently known regarding IV acetaminophen Level
III research questions several possibilities were generated. The research question that our group
chose to examine in more detail is as follows:
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Do elderly hip fracture patients who receive 1 gm IV acetaminophen every 6 hours for 48
hours post operatively require less rescue opioids and experience less opioid induced side
effects than those who receive 1 gm of oral acetaminophen every 6 hours for 48 hours.
For this proposed research project we will be manipulating the independent variable
which is the route of acetaminophen (IV or oral) administration to determine the effect on the
dependent variable of opioid consumption. If the hypothesis is supported by this research
proposal, and acetaminophen does reduce the use of opioids, this will also decrease the incidence
of opioid induced side effects. Ultimately this will result in improved care that is supported
through evidenced-based research.
Conclusion
In summary, the authors hope this research proposal provides substantial evidence to
support a research project to establish the superior efficacy of IV acetaminophen when compared
to oral acetaminophen. Furthermore, a positive correlation between the use of regularly
scheduled IV acetaminophen in the elderly, post-surgical hip fracture patient and the reduction of
opioid use will be demonstrated. By reducing opioid use, unpleasant postoperative side effects
will be diminished. Hip fracture can be a debilitating condition for the elderly patient due to pain
and immobilization. Complications from hip fractures can include delirium, functional loss, and
increased length of hospital stay. It is imperative that nurses partake in research which will
improve patient outcomes.
In Chapter 2, further developments will occur regarding Marion Good’s Pain: A balance
between analgesia and side effects theory. Included will be criticisms and rationale for the
selection of this theory. In addition, a more comprehensive literature review of the major
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concepts supporting the use of IV acetaminophen in the elderly post-surgical hip fracture
population will be included.
12
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References
Auvil-Novak, S. E. (1997). A middle-range theory of chronotherapeutic intervention for
postsurgical pain. Nursing Research, 46(2), 66-71. doi: 10.1097/00006199-19970300000002
Brett, C. N., Barnett, S. G., & Pearson, J. (2012). Postoperative plasma paracetamol levels
following oral or intravenous paracetamol administration: A double-blind randomised
controlled trial. Anaesthesia Intensive Care, 40(1), 166-171.
Chang, K. P., Center, J. R., Nguyen, T. V., & Eisman, J. A. (2004). Incidence of hip and other
osteoporotic fractures in elderly men and women: Dubbo Osteoporosis Epidemiology
Study. Journal of Bone & Mineral Research, 19, 532-536. doi: 10.1359/JBMR.040109
Cody, W. K. (5th ed.) (2013). Philosophical and Theoretical perspectives for Advanced Practice
Nursing. Charlotte, NC: Jones & Bartlett Learning.
Good, M. (2009). Pain: A balance between analgesia and side effects. In S. J. Peterson, & T. S.
Bredow (Eds.), Middle Range Theories: Application to Nursing Research (2 ed., Ch. 3).
Philadelphia, PA: Lippincott Williams & Wilkins.
Jahr, J. S., Breitmeyer, J. B., Pan, C., Royal, M. A., & Ang, R. Y. (2012). Safety and efficacy of
intravenous acetaminophen in the elderly after major orthopedic surgery: subset data
analysis from 3, randomized, placebo-controlled trials. American Journal of
Therapeutics, 19(2), 66-75. doi: 10.1097/MJT.0b013e3182456810
Macario, A., & Royal, M. A. (2010). A literature review of randomized clinical trials of
intravenous acetaminophen (paracetamol) for acute postoperative pain. Pain
Practice, 11(3), 290-296. doi: 10.1111/j.1533-2500.2010.00426.x
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Memis, D., Inal, M. T., Kavalci, G., Sezer, A., & Sut, N. (2010). Intravenous paracetamol
reduced the use of opioids, extubation time, and opioid-related adverse effects after major
surgery in intensive care unit. Journal of Critical Care, 25, 458-462. doi:
10.1016/j.jcrc.2009.12.012
Morrison, R. S., Magaziner, J., Gilbert, M., Koval, K. J., McLaughlin, M. A., Orosz, G., ... Siu,
A. L. (2003). Relationship between pain and opioid analgesics on the development of
delirium following hip fracture. Journal of Gerontology Series A: Biological Sciences
and Medical Sciences, 58(1), M76-M81. doi: 10.1093/Gerona/58.1.M76
Morrison, R. S., Magaziner, J., McLaughlin, M. A., Orosz, G., Silberzweig, S. B., Koval, K. J.,
& Siu, A. L. (2003). The impact of post-operative pain on outcomes following hip
fracture. Pain,103(3), 303-311. doi: 10.1016/S0304-3959(02)00458-X
Lenz, E. R., Pugh, L. C., Milligan, R. A., Gift, A., & Suppe, F. (1997). The middle-range theory
of unpleasant symptoms: An update. Advances in Nursing Science, 19(3), 14-27.
Pettersson, P. H., Jakobsson, J., & Owall, A. (2005, June). Intravenous acetaminophen reduced
the use of opioids compared with oral administration after coronary artery bypass
grafting. Journal of Cardiothoracic and Vascular Anesthesia, 19(3), 306-309.
doi: 10.1053/j.jvca.2005.03.006
Polit, D. F., & Tatano Beck, C. (2012). Nursing research: Generating and assessing evidence
for nursing practice (9th ed.). Philadelphia, PA: Lippincott, Williams & Wilkins.
Sinatra, R. S., Jahr, J. S., Reynolds, L. W., Viscusi, E. R., Groudine, S. B., & PayenChampenois, C. (2005). Efficacy and safety of single and repeated administration of 1
gram intravenous acetaminophen injection (paracetamol) for pain management after
major orthopedic surgery. Anesthesiology, 102(4), 822-831.
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doi: 10.1097/00000542-200504000-00019
Sinatra, R. S., Jahr, J. S., Reynolds, L., Groudine, S. B., Royal, M., Breitmeyer, J. B., & Viscusi,
E. R. (2011). Intravenous acetaminophen for pain after major orthopedic surgery: An
expanded analysis. Pain Practice, 12(5), 357-365. doi: 10.1111/j.15332500.2011.00514.x
Smith, H. S. (2011). Perioperative intravenous acetaminophen and nsaids. Pain Medicine, 12,
961-981. doi: 10.1111/j.1526-4637.2011.01141.x
Vadivelu, N., Mitra, S., & Narayan, D. (2010). Recent advances in postoperative pain
management. The Yale Journal of Biology and Medicine, 83(1), 11.
Wood, M. J., & Ross-Kerr, J. C. (2011). Basic steps in planning nursing research (7th ed.).
Sudbury, MA: Jones and Bartlett Publishers.
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Appendix
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IV Acetaminophen Research Proposal Chapter 2
Cathy Bozek, Karen Collins, Beth Kalkman, Lori Van Zoeren, and Joel Vedders
Ferris State University
Running head: CHAPTER 3
18
IV Acetaminophen Research Proposal Chapter 2
The purpose of this chapter is to further explore the major concepts of our proposal and
provide support for the theoretical framework in which it is constructed. Information related to
IV acetaminophen, the unique characteristics of the elderly, and the experience and needs of
elderly patients undergoing surgery will all be discussed. Furthermore, we will discuss
considerations related to opioid use in the elderly population. We will examine several studies
that have applied our chosen theory, Good and Moore's (1996) pain: a balance between analgesia
and side effects (BASE) as their foundational structure. The theory's flexibility and adaptability
in a variety of research demonstrates its use being an excellent choice for our study's theoretical
framework.
Theoretical Foundations
The chosen framework for this proposal is Good and Moore's (1996) theory pain: BASE.
As suggested by the theory's title, Good and Moore sought to provide optimal pain relief while
minimizing the negative side effects of pain management modalities. Understanding the
background to the theory will assist in establishing its credibility for use.
The Agency for Health Care Policy and Research (AHCPR) published recommendations
in 1992 that guide adequate pain management in postoperative patients (Good, 1998). The
recommendations stress the importance of educating patients on how to communicate levels of
pain and how to assess if pain is not adequately relieved after receiving medication. While these
guidelines became the gold standard for clinical practice in postoperative pain management at
that time, Good and Moore found that these guidelines were not in a form to be tested (Good,
1998). The guidelines needed a theory to assist in "concepts and propositions at an intermediate
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level of abstraction" (Good, 1998, p. 120). Their theory was then formulated from the AHCPR
guidelines.
Good and Moore's resultant theory, pain: BASE stresses the importance of patient
teaching with an emphasis on the nurse’s responsibility, as well as the patients themselves, to
assess and reassess pain. Pharmacologic treatments, along with the effectiveness and side effects
of the treatments, are also evaluated. Good and Moore (1996) discuss the importance of nurses
having access to descriptive theories which guide practice related to pain management.
Propositions of this theory were discussed in Chapter 1 which predicts outcomes related
to postoperative pain management. The two main concepts that Good (1998) discussed were: (a)
the balance between analgesia and side effects, and (b) decreased pain and side effects (p. 122).
Concepts that are more specific can then be researched by delving into the elements of pain
versus the effects of sequelae such as nausea and vomiting.
Good (1998) stressed the importance of a multimodal delivery of care to decrease pain.
Involved in this method of care are: (a) a comparison of medications and how the medications
are delivered; (b) the use of a pharmacological adjuvant in comparison to not using an adjuvant;
and (c) the use of non-pharmacologic adjuvants, such as cold therapy, music, imagery, and
massage. These measures all assist the researcher in developing a proposal that answers the
hypothesis in question. Several articles utilize BASE, and the relationship between their theory
and our proposed research will be demonstrated.
Study One
Good and Moore’s theory of pain alleviation is the underlying framework for a study
done by Benson, McMillan, and Ong (2012). Their study focused on how potent pain
medication (bupivacaine spinal with intrathecal morphine), along with other opioids and non-
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pharmacologic adjuvants (i.e. warming blankets), can promote a balance between analgesia and
side effects. The aim of this prospective, randomized controlled study was to determine the
efficacy of a patient-controlled, forced-air warming gown in optimizing a patient’s perioperative
body temperature and in decreasing postoperative pain after a total knee arthroplasty (TKA).
Limitations of the study were listed as: (a) lack of standardization of administration of anesthetic,
(b) the study was not a blinded study, (c) temperature variations were not monitored in the
operating rooms, (d) a specific gown temperature was not tested, and (e) the temperature of the
warming cupboard was not monitored and may have resulted in variable blanket temperatures.
Findings of the study demonstrated that opioid consumption was decreased in those patients who
were warmed with a warming gown (Benson, McMillian, & Ong, 2012).
Study Two
A retrospective study of two hundred fifty-seven charts, conducted by Otten and Dunn
(2011), used BASE to promote a multimodal system for postoperative pain control following
TKA. The prescriptive theory BASE was utilized as foundation of this study because: (a) the
population of interest is alert adults, (b) pain is usually severe after TKA, (c) multimodal
therapeutics are needed, and (d) side effects of pain medication administration are troublesome
(Otten & Dunn, 2011). Patients who received “all 3 anesthetic modalities (intrathecal morphine
sulfate, single-shot femoral nerve block, and wound catheter) had better pain control
postoperative TKA” (Otten & Dunn, 2011, p. 373) and requested less rescue opioids.
Study Three
A third study utilizing Good and Moore’s theory is a “descriptive profile of pain in 80
women during the first two days after gynecologic surgery” (Good et al., 2000, p. 96). Pain was
scored before and during ambulation on both day one and day two after surgery. Sleep was also
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addressed, as pain can often be a cause of nighttime sleep disturbances (Good et al., 2000). The
recovery of gastrointestinal function was also addressed. It was found that post-surgical nurses
should help patients set realistic goals for pain control after gynecologic surgery, provide
adequate analgesic medications, assess and reassess the patients for pain, and provide nonpharmacological adjuvants (relaxation or soft music tapes). All of these, in conjunction with one
another, produce less postoperative complications (Good et al., 2000). A reported limitation of
this study was the fact that sleep medications were not accounted for. In addition, the instrument
used to address the patient’s sleep had “no known reliability or validity” (Good et al., 2000, p.
102).
Study Four
Blanchard and Murnaghan (2010) used BASE to lend support to their single case study of
a nursing student's experience of working with a multimodal approach to pain management in a
patient with acute chest pain in the emergency room. They stress the correlation of BASE to the
Prince Edward Island conceptual model. A collaborative, systematic approach to pain is evident
with assessment and reassessment. The article clearly illustrates the use of multimodal
interventions with: (a) patient teaching and goal setting, (b) attentive care with assessment of
pain and interventions, and (c) pharmacological and non-pharmacologic treatments (Blanchard &
Murnaghan, 2010).
Study Five
Voshall, Dunn, and Shelestak (2012) conducted a study “to examine nursing faculty’s
knowledge of pain management” (p. 2). BASE was the theoretical framework for this
descriptive correlational study as well as King’s theory of goal attainment. Both theories
emphasize patient teaching with mutual goal setting, regular assessment of pain, possible
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pharmacologic modalities, evaluation of side effects if medication is used, and the assessment of
interventions (Voshall et al., 2012).
Voshall et al. (2012) addressed the relationship of nursing faculty’s age, educational
level, pain management preparation and length of time as a practicing nurse. Additionally, the
length of time as an instructor, length of time teaching pain management in the classroom, and
additional continuing education in pain management were studied. Results of the study indicated
that nursing curriculum “may need to be strengthened in the topic of pain management” (Voshall
et al., 2012, p. 10).
Based on these five articles, we are in support of the use of Good and Moore’s theory,
BASE. Multimodal approaches to pain management should be in place for the safety of our
patients, thus decreasing potentially debilitating side effects. BASE addresses multimodal
therapy (IV acetaminophen and opioid use), attentive care (regularly scheduled doses of IV
acetaminophen, and assessment and reassessment of pain and side effects), and patient
participation (with patient teaching regarding medication and pain management).
Literature Review of Major Concepts
Elderly Population Considerations
The elderly population is rapidly growing within the United States (U.S.). This is
attributed to not only the aging baby boomers, but also to advances in health care and illness
prevention that are making it possible for humans to live longer. By 2030, there is expected to
be 71.5 million people over the age of 65 within our country (Bruckenthal, 2010). The elderly
will constitute 20% of the nation's entire population (Kim & Geitsfeld, 2008). Although the
American Nurses Association (ANA) has published specific standards of practice for
gerontological nursing, schools of nursing may not adequately prepare student nurses to provide
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care in the specialty area of geriatrics (Corbett, 2011). As this aging and vulnerable segment of
the population grows, it is imperative that nurses gain a better understanding regarding the
unique characteristics related to aging and the pain management needs of this group.
Physiological changes of aging. Normal aging involves the slow deterioration of
multiple body systems (Chodko-Zajko et al., 2009). The resultant physiological changes
include: decreased muscle mass with accompanying reduced strength and flexibility, decreased
cardiovascular function with reduced blood volumes and increased blood pressure at rest, an
initial increase in weight with slow decline after age 70, and a decline in bone density (ChodkoZajko et al., 2009). Together, these factors can contribute to an increased risk of fall and injury.
“Regular exercise can minimize the physiological effects of an otherwise sedentary lifestyle and
increase active life expectancy by limiting the development and progression of chronic disease
and disabling conditions" (Chodko-Zajko et al., 2009, p. 1510). Since only 50-60% of patients
return home to their independent life after sustaining a hip fracture (Koren-Hakim et al., 2012),
the ultimate goal for nursing should be returning the elderly patient to physical activity as soon
as possible following an injury such as a fractured hip.
Pain experience. Some causes of pain in the elderly are irreversible (Bruckenthal,
2010). McCleane (2010) echoes this sentiment stating "we are not at the position where we
could realistically claim that pain is an entirely treatable symptom or that pharmacological
modalities available for such treatment are devoid of significant side effects" (p. 183). In the
elderly person there can be a loss of serotonin and norepinephrine receptors that assist in the
suppression of pain (McCleane, 2010). Also, neurological changes in the aging body include
loss of myelination in the fibers of the peripheral nervous system. These neuropathies may cause
significant chronic pain. The existence of chronic pain in some elderly patients has led to
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misdiagnosis and mistreatment related to the source of pain (Brown, Kirkpatrick, Swanson, &
McKenzie, 2011; McCleane, 2010). Care providers may wrongly attribute a person's pain to one
of the common chronic conditions of aging instead of looking for an acute source. It is important
to safeguard one's self against stereotyping elderly patients experiencing pain.
McCleane (2010) reports the results of a number of studies have shown elderly persons to
have an increased threshold for pain. Meaning, elderly patients report the experience of pain at
more extreme measures than younger people; that is, it takes more pain to feel pain. However,
elderly people are less tolerant of experiencing pain. Whereas a younger individual may be
exposed to pain and accept it with a sense that it is temporary, elderly individuals may fear that
the pain, once experienced, will not cease (McCleane, 2010).
The elderly person's tolerance for pain or ability to cope with pain may be directly
associated to his or her psychological, biological, and social health (Bruckenthal,
2010). According to Kim and Geistfeld (2008), "social isolation commonly occurs among older
adults as a consequence of poor health, retirement, and the loss of a spouse and friends" (p. 3).
Reciprocally, the experience of pain may further cause social isolation (Brown, Kirkpatrick,
Swanson, & McKenzie, 2011).
Postoperative pain management in the elderly is often complicated by the frequent
incidence of poly-pharmacy in the population (Bruckenthal, 2010). Many elderly persons are
taking a number of medications for chronic conditions. The risk of side effects and interactions
between medications make appropriate prescribing difficult. "Both inappropriate prescribing and
medication underuse are common in the elderly, as is the under treatment of pain in this patient
population" (Bruckenthal, 2010, p. S23). Therefore, it is important to partner with the elderly
patient to determine strategies to successfully manage his or her pain.
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Surgical Considerations in the Elderly/Opioid side-effects
According to the Centers for Disease Control and Prevention (CDC, 2012) in 2007,
281,000 hospital admissions were related to hip fracture patients who were 65 years and older.
Hip fractures within the geriatric population may result in a major disability with an overall
reduced quality of life. Our goal is to positively impact the key outcomes of surgery for this
population and aid in returning the individual to the highest level of self-care and quality of life.
Ambulation. Post-surgical early ambulation within the elderly hip fracture population is
a necessity to achieve long-term and short-term goals. According to a review of clinical practice
guidelines for the management of proximal femoral fractures, early assisted ambulation
accelerated functional recovery and is connected with an increase in direct discharges home
(Mak, Cameron, & March, 2010). With optimal pain relief, early ambulation can be achieved
(Olsson, Karlsson, & Ekman, 2007). Early ambulation is necessary to prevent pulmonary
complications, thromboembolism, and pressure ulcers, which are all a frequent complication
after surgical hip repair (Roth, Kammerlander, Luger, & Blauth, 2010).
Nutrition. Nutritional status is another issue to consider when caring for an elderly hip
fracture patient. According to Koren-Hakim et al. (2012), up to 58% of patients with a hip
fracture have been found to be malnourished. This can be caused by a number of issues; first,
nutritional deficits can result from aging and poor cognitive status (Koren-Hakim et al., 2012).
Additionally, preoperative fasting, surgical delays, pain, nausea, and vomiting can contribute to
malnutrition for the elderly while in the hospital (Koren-Hakim et al., 2012). A retrospective
study was performed which included 215 elderly hip fracture patients who were surgically
repaired between the years 2007-2009. Ninety-five patients were well-nourished, ninety-five
were at risk for malnutrition, and twenty-five were malnourished (Koren-Hakim et al.,
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26
2012). Fewer hospital readmissions occurred in the well-nourished group (36%) compared to the
high risk and malnourished groups (64%) (Koren-Hakim et al., 2012). Mortality rates were also
lower at thirty-six months within the well-nourished group (22%) compared to the at-risk group
(40%), and the malnourished group (50%) (Koren-Hakim et al., 2012). The results of this study
show the importance of elevating nutritional status in the elderly hip fracture population and the
positive effects it can have on the outcomes. Mak, Cameron, and March (2010) promote
utilization of protein and energy supplements in this population to support an adequate
nutritional status.
Postoperative cognitive dysfunction. Elderly patients who have undergone surgery
often suffer from postoperative cognitive dysfunction (POCD) (Halaszynski, 2009). Halaszynski
(2009) reports a potential cause of POCD is a decrease in the stress response during opioid
consumption, which can then lead to postoperative delirium. Sleep impairment can also result in
decreased postoperative function levels, fatigue, and POCD (Halaszynski, 2009). Postoperative
delirium increases length of hospital stays and is associated with poor long-term outcomes
(Marik, 2010).
Opioid Use in the Elderly
Due to the changing physiology associated with aging, the elderly experience negative
side effects of opioids related to absorption and metabolism of the drugs themselves. The
possible side effects range from nausea, constipation, urinary retention, central nervous system
adverse effects, pruritus, respiratory depression, and opioid-induced hyperalgesia (Chau, Walker,
Pai, & Cho, 2008). A reduction in muscle mass and an increase in body fat can increase the
amount of drugs available in the system for a longer period of time that can increase the opioid’s
side effects (Huang & Mallet, 2012). Reduced hepatic function due to aging can reduce the
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hepatic clearance of the drug by 30-40% (Huang & Mallet, 2012). A decline in renal function
must also be considered as metabolites that are not excreted completely can accumulate (Huang
& Mallet, 2012).
The use of opioids also increases the risk of falls. According to Huang and Mallet
(2012), the use of codeine puts the patient at a 127% greater risk of falls. Opioids also increase
the risk of drug-to-drug interactions that create an increased risk of falls. A goal of healthcare
providers should include limiting side effects of opiates while still properly controlling pain for
their patients (Chau, Walker, Pai, & Cho, 2008). Utilizing other pain therapies (i.e. IV
acetaminophen) along with decreasing the use of opioids will yield superior outcomes for the
elderly.
IV Acetaminophen
Given the rising costs of health care in the U.S., hospitals are seeking new ways to
minimize pain in postoperative populations in order to reduce length of stays. The use of
multimodal medication therapies is on the rise. White (2005) studied the use of multimodal
medication therapies and the changing role that IV acetaminophen and other non-opioid
analgesics can provide. White (2005) wrote that IV acetaminophen is probably the safest and
most cost effective of all the non-opioid options on the market at the time of publication. In
addition, IV acetaminophen decreased morphine use in postoperative patients by 22 % to 46 % in
patients who had major orthopedic surgery (White, 2005).
History of IV acetaminophen. IV paracetamol, also referred to as IV acetaminophen
for the purposes of this paper, has been available in Europe since 2001 (Jones, 2011). However,
it was not approved for use in the U.S. until November of 2010 (Smith, 2011). Prior to its
approval in the U.S., IV acetaminophen was available for use in sixty other countries, involved
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in sixty-nine clinical trials, and more than 400 million doses were administered (Barkin,
2011). IV acetaminophen was established as a safe and effective drug that could be used as part
of a multimodal treatment regimen for postoperative pain.
IV acetaminophen has been available in another form known as
propacetamol. Propacetamol was never approved for use in the U.S. and although previously
used in Europe, it is currently being phased out in favor of paracetamol (Pergolizzi, Raffa,
Tallarida, Taylor, & Labhsetwar, 2011). Propacetamol is a prodrug of IV acetaminophen and is
a diethylglycidyl ester of acetaminophen; once it is administered intravenously it is converted to
acetaminophen within seven minutes (McNicol et al., 2011).
A meta-analysis was performed by McNicol et al. (2011) which reviewed thirty-six
studies to compare the effectiveness and safety of IV acetaminophen verses propacetamol. A
total of 712 patients received IV acetaminophen, 1431 were treated with propacetamol, and 1048
received a placebo (McNicol et al., 2011). Combined data from nine studies which compared
each form of drug to a placebo showed a 50% reduction in pain over six hours in 26% of those
who received propacetamol, and 27% in those receiving IV acetaminophen (McNicol et al.,
2011). These results translated in to a 30% reduction in opioid use (McNicol et al.,
2011). Thirteen of the studies also reported no statistical difference in nineteen different adverse
events reported when compared to placebo (McNicol et al., 2011). One significant difference
reported between IV acetaminophen and propacetamol was injection site pain during
administration (McNicol et al., 2011). Of those who received propacetamol, 23% reported pain
at the injection site compared to just 2% in those receiving IV acetaminophen (McNicol et al.,
2011). An additional advantage of IV acetaminophen over propacetamol is that propacetamol
needs to be reconstituted prior to administration, while IV acetaminophen is ready to use in its
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29
current solution state (McNicol et al., 2011). Contact dermatitis has also been reported by health
care workers who handle propacetamol during its reconstitution (McNicol et al., 2011). The
meta-analysis conducted by McNicol et al. (2011), concluded that IV acetaminophen and
propacetamol yielded similar results related to safety and effectiveness in controlling pain. IV
acetaminophen held an advantage because it did not need reconstitution and had a low incidence
of pain upon infusion (McNicol et al., 2011). This may also be one reason propacetamol is not
available in the U.S.
Advantages of IV acetaminophen. IV acetaminophen is advantageous for the
postoperative or orthopedic patient due to its relatively low side effects rate. In the elderly, this
is important, as opioids may be associated with respiratory depression, hypotension, dizziness,
confusion, and delirium (Lachiewicz, 2013). Lachiewicz (2013) suggests that multimodal pain
protocols should be considered for all perioperative orthopedic patients. IV acetaminophen has a
rapid onset; “the median time to reach maximum plasma concentration (Tmax) . . . is 15
minutes” (Lachiewicz, 2013, p. 16). The Tmax for oral acetaminophen is 45 to 75 minutes, and
the Tmax of rectal administration is 3 to 4 hours (Lachiewicz, 2013). The half life of IV
acetaminophen is 3.2 hours (Lachiewicz, 2013).
Gaps in the Literature
Our comprehensive literature review yielded information related to the major concepts of
our proposed study. However, remaining gaps were identified. Although it is clear that
improved pain management facilitates early ambulation, no literature was located related to IV
acetaminophen's use in improving functional outcomes. These include: early ambulation,
decreasing the well-known side effects of opioids, increasing compliance with physical therapy,
and promoting early discharge home for the elderly patient. Furthermore, there was no evidence
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of research utilizing BASE in our chosen population of the elderly postoperative hip fracture
patient. Two articles reflected on TKA, one article on chest pain, one article on gynecologic
surgical pain, and one on nursing faculty’s knowledge of pain.
Conclusion
As health care costs continue to rise in the U.S., hospitals are seeking ways to control
postoperative pain, and thus shorten the length of stay. Multimodal therapy has been proven to
be effective in this endeavor. The use of IV acetaminophen in the elderly postoperative hip
fracture population has been shown to significantly decrease postoperative pain, along with the
adverse side effects of opioid use, as the elderly metabolize opioids in a different manner than do
their younger counterparts. However, the use of IV acetaminophen and its effect on functional
outcomes has not been documented. Chapter Three will focus on the design and methodology
for our research proposal. We will discuss the research design, how to choose the population
sample and collect data, as well as a focus on the validity and reliability of this
research. Additionally, we will consider ethical considerations and discuss limitations of the
project.
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31
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IV Acetaminophen Research Proposal Chapter 3
Cathy Bozek, Karen Collins, Beth Kalkman, Lori Van Zoeren, and Joel Vedders
Ferris State University
CHAPTER 1
36
IV Acetaminophen Research Proposal Chapter 3
For more than ten weeks, the research team consisting of Bozek, Collins, Kalkman,
VanZoeren, and Vedders has compiled data to rationalize the need for a research study to
validate our proposed hypothesis that the use of IV acetaminophen in the elderly post-operative
hip fracture patient is expected to decrease the consumption of opioids. Chapter 1of the proposal
focused on the introduction to our research project. An abbreviated literature review was
performed based upon our stated hypothesis; the research question was identified; and, a
theoretical framework was chosen and discussed.
In Chapter 2, a comprehensive literature review provided a detailed explanation of the
key concepts related to the proposed study. Gaps in the research were revealed related to the
elderly hip fracture population and optimal standards to treat pain. In addition, there were
limited studies comparing IV versus oral acetaminophen using a multimodal approach. This
confirmed the use of Good and Moore's (1996) theoretical framework pain: a balance between
analgesia and side effects (BASE) as an appropriate choice to test the hypothesis. It is believed
that a multi-modal approach to pain control will have an effect on outcome measures for these
patients including decreased untoward side effects, decreased length of hospital stay, earlier
ambulation, and optimal post-operative functioning.
In Chapter 3, the focus will be on the design and methodology of the proposed study.
The specific research design, sampling plan and method of data collection will be addressed.
Additionally, reliability and validity of the chosen instruments will be discussed. As in any
research study, we will present the limitations and ethical concerns of this proposal. It will be
imperative to choose the proper design and methods to carry out accurate data collection that is
untainted with excessive rigor. By the end of this final chapter, the reader should have a clear
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37
understanding of the entire research proposal and the planned methods for conducting the
research.
Research Design
The study we are proposing is one of experimentation; more specifically, we are planning
a type of quantitative research design known as a three-armed, double-blind, placebo controlled
randomized controlled trial (RCT). In a RCT, participants are randomly assigned to two or more
groups; one group receives standard treatment and the other group (or groups) receives the
experimental intervention (Stanley, 2007). There are three defining characteristics of a RCT:
manipulation, control, and randomization (Polit & Beck, 2012). We will be determining the
effect of manipulating the route of acetaminophen administration on opioid consumption in the
chosen population for 48 hours post-operatively. In addition, we will be providing a
counterfactual (or control group) which helps to validate the relationship between the
independent and dependent variables by removing the independent variable from one group in
the sample (Polit & Beck, 2012). By including a non-intervention group, we can better
determine that the observed results are attributable to the independent variable (Polit & Beck,
2012). Furthermore, we will randomly assign subjects from the study sample to one of three
groups: IV administration of acetaminophen, oral administration of acetaminophen, or no
acetaminophen administration. Randomization helps to remove the potential for researcher bias
(Stanley, 2007; Wood & Ross-Kerr, 2011).
To double-blind this study, where caregiver and patient are unaware of the treatment
assignment (Polit & Beck, 2012), it will be necessary for all participants to receive IV and oral
"medication" simultaneously every six hours. For two of the groups, one route will contain
acetaminophen whereas the other will contain a placebo. In the control group, neither route will
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38
contain acetaminophen. Providing the intervention in this manner will protect against the
Hawthorne effect, an elevated response due to participation in a research study (Polit & Beck,
2012). All other care provision will be identical between groups.
An area of consideration in an RCT is the principle of clinical equipoise (Stanley, 2007).
Under this ethical principle, a researcher cannot intentionally submit research participants to
interventions which are knowingly sub-standard (Stanley, 2007). Therefore, all groups within a
study must receive treatment that is, at the minimum, provided at the current accepted standard
of care. Because the literature supports opioids in standard pain management following
orthopedic surgery (Vadivelu, Mitra, & Narayan, 2010), opioids will be available and utilized
within our study. The question our research seeks to answer is whether intravenous
acetaminophen will decrease the use of opioids in the target population.
Setting and Sample
Setting
The setting for our proposed research study is a dedicated orthopedic care unit
specializing in fracture repair located at a Level 1 regional trauma center in West Michigan. It is
estimated that this facility repairs more than 400 intertrochanteric (IT) fractures every year
providing a sufficiently large population from which to recruit our study sample. Furthermore,
this trauma center is known for its on-going participation in research and its provision of stateof-the-art care. Performing our proposed research in this single-site setting will lend credibility
to our proposed research, ease sample recruitment, result in consistent quality service to study
participants, and also provide a supportive environment for novice researchers.
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Sample
As stated in the research hypothesis, our population of interest is the elderly (age 65 and
older) hip fracture patient. Polit and Beck (2012) emphasize that a target population is best
represented by a sampling which accurately reflects the common features of the desired group.
Chapter 2 of our proposal clearly describes the unique characteristics of the elderly. Inclusion of
these characteristics will be intentional during the recruitment process thereby strengthening the
study's external validity (Wood & Ross-Kerr, 2011).
Conversely, in order to strengthen the internal validity of our study, some variability
within the sample must be controlled (Polit & Beck, 2012). For example, there are a variety of
orthopedic repair techniques which differ in degree of invasiveness based on the presentation of
the hip fracture. To decrease the potential risk of study results being attributed to variations in
methods of repair, only those patients undergoing an open reduction internal fixation (ORIF) for
an IT fracture will be eligible for study inclusion. After careful consideration by the research
team the following eligibility criteria have been determined:
Inclusion criteria:
1. Age: 65 years and older.
2. Gender: Male or female.
3. Race: No limitation.
4. Cognition: Alert and oriented as determined by a satisfactory score on the MiniMental State Exam (MMSE) (see Appendix A).
5. Social: Family support identified.
6. Nutritional status: Adequate.
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7. Medication: No allergies to acetaminophen or opioids. No identified potential drugdrug interactions between acetaminophen or opioids and patient's current medication
list.
8. Injury: Isolated IT fracture.
9. Literacy: English speaking and/or reading, or ability to give informed consent
through use of interpretive services.
Exclusion criteria:
1. The inverse to any of the above criteria.
2. Current treatment with opioids for conditions such as chronic pain.
3. Existence of severe liver disease.
4. Inability to swallow.
Regulatory criteria:
1. The study must have signed approval by the appropriate governing body at the
proposed research site. If Institutional Review Board (IRB) approval is deemed
necessary, this will be achieved and documented.
2. A signed informed consent must be documented and kept available for each study
participant.
3. Ethical concerns must be addressed and have satisfactory resolution prior to
conducting the study (Wood & Ross-Kerr, 2011).
Intact cognition will be determined through the administration of the MMSE by
individuals trained in the administration and scoring of this test. This 10-15 minute test includes
examination of memory, orientation, attention, recall and abstract thinking (Feliciano, Baker,
Anderson, LeBlanc, & Orchanian, 2011). The MMSE has been extensively researched and
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41
validated with "interrater correlations of r=.82 and test-retest reliability ranging from r=.89 to
r=.98 and sensitivity and specificity rates of 71% and 95.6% in hospitalized patients" (Feliciano
et al., 2011, p.2). Due to the administration time of this test being considerably less than that of
another commonly used test, the Cognitive Assessment of Minnesota (CAM) which takes 35-45
minutes to administer (Feliciano et al., 2011, p.2), the choice was made to use the MMSE.
Because we have identified a specific setting for this study and we have a target
population of the elderly hip fracture patient, consecutive sampling will be used to obtain the
necessary subjects. A power analysis will be performed by a research statistician to determine
the necessary sample size. Per Polit and Beck's (2012) definition of consecutive sampling, all
individuals who present to the trauma center during sample recruitment and meet the eligibility
criteria for the study will be approached for study inclusion. All information related to the study
will be discussed with the individual in order to obtain informed consent. Once consent is
gained, the patient will be enrolled in the study and randomized into a particular treatment group.
Methods
In order to have a study that is free of bias, blinding must occur. Blinding eliminates
three types of bias. The first type is expectation bias; if the patient is unaware of which drug is
being administered the outcome cannot be influenced by the patient's expectation of its efficacy
(Polit & Beck, 2012, p.212). Secondly, performance bias is eliminated; if the care provider is
unaware of which agent is being administered, it will eliminate differences in care provided to
different groups (Polit & Beck, 2012). For example, if the nurse was aware the patient was
receiving placebo only, he or she may implement other methods of pain control such as ice to the
surgical site, or spend more time teaching relaxation techniques. The third type of bias, detection
bias, will be controlled by utilizing the Numeric Rating Scale (NRS) to measure pain which
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allows no room for recording variations in outcome variables. This method provides
transparency which allows for multiple researchers to deliver the same method of assessment and
acquire the same results (Burns & Groves, 2007).
Study Variables
Post-operative order sets will be developed for the purpose of the study through a
collaborative effort by the orthopedic surgeons, nursing staff, and researchers. The orders will
include routine post-operative orthopedic orders with the addition of the administration of the
randomized intervention. The primary investigator (PI) will draw an envelope containing postoperative orders from a box holding the appropriate number of envelopes as determined by the
power analysis.
Once the patient is awake, alert, and able to swallow pills following surgery, he or she
will receive administration of the first randomly assigned dose as determined by the post-op
orders. The pharmacy will then be notified of the time of administration of this initial dose and
will schedule consecutive doses every six hours for 48 hours on the electronic medication
administration record (EMAR). Prior to the administration of each dose the patient's pain will be
assessed and recorded using the eleven point NRS with numbers ranging from zero to ten. Zero
represents no pain while ten represents the worst pain possible (see Appendix B).
According to Hawker, Mian, Kendzerska, and French (2011), the advantage of the NRS
scale over the visual analog scale (VAS) is its simplicity, scoring, and the fact that it can be
administered both verbally and in writing. It also takes less time to administer, is easy to
complete, and can be used across cultures and languages (2011). The NRS has also shown high
reliability and validity. "High test-retest reliability has been observed in both literate and
illiterate patients. For construct validity, it is shown to be highly correlated to the VAS"
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(Hawker et al., 2011, p. 242). Hjermstad et al. (2011) echo those results; the NRS and the VAS
were viewed as the most reliable and easiest to use. According to Flaherty (2012), the NRS is the
most widely utilized pain intensity scale administered in older adults. We, therefore, felt this
measurement tool was best suited for our study.
The patient's pain will also be scored and recorded 30 minutes after administration of the
study dose in the electronic medical record (EMR). Additionally, the facility's routine ongoing
pain assessment protocols will be followed. Opioids will be administered for further pain control
when requested by the patient. Opioid usage during the 48 hour postoperative period will be
tallied from the EMR. The PI will be able to gather this information by chart review after the 48
hour time frame has ended. This information will then be submitted for data analysis.
Data Analysis
Through a power analysis, we expect to recruit a large enough sample size to use the
multivariate analysis of variance (MANOVA) to analyze and compare the data. MANOVA is an
extension of the analysis of variance (ANOVA); the parametric procedure for testing differences
between means when there are at least three groups to be studied (Polit & Beck, 2012).
MANOVA will also increase control for the proposed research, due to its ability to look at the
significance of the differences between dependent variables (Polit & Beck, 2012). MANOVA
compares the significance of differences for multiple dependent variables (Polit & Beck, 2012, p.
446). If, as per the guidance of an experienced researcher, we are unable to obtain the necessary
sample size, a simple ANOVA will be performed (Ford, personal communication, April 15,
2013). Utilization of a double-blind technique will have patients serve as their own controls for
the comparison between the two routes of administration of acetaminophen.
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In addition to pain and opioid use, data will be extracted from the EMR related to falls,
constipation, delirium, nausea and vomiting. Data will be entered into the most current addition
of the Statistical Package for the Social Sciences (SPSS). A paid researcher familiar with this
software will enter the data. Descriptive statistics will compare the mean, mode, and median of
the amounts of rescue opioids used in conjunction with the route of acetaminophen or placebo.
By utilizing SPSS to input data and perform a two-tailed test, we will test at the 0.05 level of
significance. Rejection of our null hypothesis will occur if the results are greater than 0.05 (Polit
& Beck, 2012, p.409). We can also run a multiple linear regression in SPSS to view the
relationship between the multiple variables or provide scatter plots which will show the
relationship between the independent and dependent variables.
Reliability and Validity
A Level III research study “demands the highest degree of validity and reliability testing”
(Wood & Ross-Kerr, 2011, p. 203). For this reason, we have chosen to utilize well-known
measurement tools that have been tested and proven to be reliable and valid. Reliability is the
“degree of consistency or dependability with which an instrument measures an attribute” (Polit
& Beck, 2012, p. 741). This equates to the measure’s stability, consistency, or dependability.
These components need to be accurate for the study to be reproducible. Validity is a quality
criterion referring to the degree by which inferences made in a study are accurate and well
founded (Polit & Beck, 2012). Validity in measurement is the “degree to which an instrument
measures what it is intended to measure” (Polit & Beck, 2012, p. 745).
In this proposed study, control of experimental conditions will be enhanced by keeping
procedures as consistent as possible. For example, as we are focusing our study on one type of
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hip fracture repair, ORIF of an IT fracture, discrepancies in surgical technique will be
minimized. Equipment will also remain constant.
In addition, we will utilize a well-known pain scale. The NRS has been chosen due to its
ease in use with both the patients and the nursing staff. The reliability and validity of the NRS
was discussed earlier in this paper, on page 8. The nursing staff will receive instruction by one
trainer regarding the utilization of the NRS pain scale and the importance of documenting pain
accurately throughout the pre- and post-intervention periods. Using one trainer will decrease
teaching bias among several different trainers.
Another measurement tool, the Confusion Assessment Method (CAM), will be used to
detect delirium among our chosen population post-operatively (see Appendix C). The CAM tool
is valid and shows high interrater reliability (kappa=0.79-0.96) (Tate & Happ, 2012, para
4). This test is also easy to administer with minimal training. Testing time is about 2 minutes
(Tate & Happ, 2012). Both the NRS and the CAM scales will be serially addressed at regular
prescribed intervals and documented in the EMR.
Limitations
Despite careful preparation and planning, there will be questions that remain unanswered
after conducting a research study. It is important for researchers to have appropriate
expectations for their work. This requires a discussion related to the potential limitations of the
research proposal. For example, limitations of this study include the possibility that despite
training and education of nursing staff and test administrators related to the goals of this study,
there may still be variance in administration of the intervention, patient assessment, and
documentation of study data.
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Due to the age of our sample population, attrition is also a very real threat to this study's
success. Although efforts have been made through the inclusion criteria to reduce the risk of
attrition, there still remains the possibility that untoward events will cause unavoidable removal
from the study. Possible reasons for removal include intolerance of medication administration,
error in medication administration, unforeseen medical events, development of delirium, or
death.
In addition, this study is targeted to the elderly population. Reasons for this have been
validated in earlier chapters of this study proposal. This does mean, however, that findings from
this study may not be applicable to people of different age groups.Additional limitations may be
discovered after completion of the study and analysis of the data.
Ethical Concerns
When performing research on human beings, especially a vulnerable population such as
the elderly, there are ethical concerns to be considered. Involved with this, is the safeguarding of
ethical concepts such as beneficence, preservation of human dignity, and justice (Polit & Beck,
2012). The authors of this research proposal will ensure that the study is performed with the
utmost integrity by qualified personnel.
Informed consent will be obtained in writing after full disclosure of the study's purposes
has occurred. Potential participants will have the opportunity to ask questions and request
clarification related to the study before signing consent. Participants will also be fully aware of
their right to withdraw from the study at any time without question. Participants will be asked to
grant permission for dissemination of study results, should this study be recommended for
publication.
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As within any healthcare system, confidentiality of patient information and privacy will
be maintained. Participant anonymity will be further protected by assigning identification
numbers to de-identify individual patient data for reference purposes during data extraction from
the EMR. The PI will take the obtained information and deliver it to the paid research statistician
who will have signed an agreement of confidentiality prior to handling study data.
In addition, the researchers believe the results of this study to be of potential significant
benefit to the elderly hip fracture population. Standard post-operative pain management will not
be withheld from these patients thereby protecting subjects from clinical equipoise. Rather, by
adding IV acetaminophen as an adjunct therapy, we believe there will be a change in postoperative opioid usage.
Finally, as previously stated in the text, the proposal will be submitted for review to the
IRB of the proposed study site. The IRB of any facility conducting a research study must
approve all research prior to implementation to safeguard patient protection and the ethical
integrity of the research (ANA, 2010). This board, consisting of experts in research and risk
management, will examine the proposal to disclose any unaddressed ethical concerns specific to
performing this study on the elderly hip fracture population. Any identified concerns will be
corrected by the researchers prior to re-submission of the proposal for IRB approval.
Summary
In summary, Chapters 1 and 2 have developed rationale for our research proposal in
depth. A hypothesis has been developed, research questions posed, literature reviewed,
significant variables discussed, and a theoretical framework created. Now, in Chapter 3,
specifics related to the research design, methods, setting and sample including inclusion criteria,
data analysis, reliability and validity of our chosen tools, limitations, and ethical considerations
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have been addressed. It is the opinion of these authors that this research proposal has the
potential to provide valuable information to ensure evidence based care for this vulnerable
population.
48
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References
American Nurses Association (ANA, 2010). Guide to the code of ethics for nurses: interpretation
and application. Silver Spring, MD: Nursesbooks.org.
Burns, N., & Groves, S. K. (2007). Understanding nursing research (4th ed.). St Louis, MO:
Sanders Elsevier.
Feliciano, L., Baker, J. C., Anderson, S. L., LeBlanc, L. A., &Orchanian, D. M.
(2011).Concurrent validity of the cognitive assessment of Minnesota in older adults with
and without depressive symptoms.Journal of Aging Research, 2011, 1-6.
http://dx.doi.org/10.4061/2011/853624
Flaherty, E. (2012). Best practices in nursing care to older adults. Retrieved from
http://consultgerirn.org/uploads/File/trythis/try_this_7.pdf
Hawker, G. A., Mian, S., Kendzerska, T., & French, M. (2011).Measures of adult pain. Arthritis
Care and Research, 63(11), 240-252. http://dx.doi.org/10.1002/acr.20543
Hjermstad, M. J., Fayers, P.M., Haugen, D. F., Carceni, A., Hanks, G. W., Loge, J. H., Kaasa, S.
(2011). Studies comparing numerical rating scales for assessment of pain intensity in
adults: a systematic literature review. Journal of Pain and Symptom Management, 41,
1073-1092. http://dx.doi.org/10.1016/j.jpainsymman.2010.08.016
Polit, D. F., & Beck, C. T. (2012). Nursing research: Generating and assessing evidence for
nursing practice (9th ed.). Philadelphia, PA: Lippincott, Williams & Wilkins.
Stanley, K. (2007). Statistical primer for cardiovascular research: Design of randomized
controlled trials. Circulation, 115, 1164-1169.
http://dx.doi.org/10.1161/CIRCULATIONAHA.105.594945
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Tate, J. A., &Happ, M. B. (2012).The confusion assessment method for the ICU (CAM-ICU)
[Issue brief 25]. Retrieved from The Hartford Institute for Geriatric Nursing, New York
University, College of Nursing. www.harfordign.org
Vadivelu, N., Mitra, S., & Narayan, D. (2010). Recent advances in post-operative pain
management. Yale Journal of Biology and Medicine, 83, 11-25.
Wood, M. J., & Ross-Kerr, J. C. (2011). Basic steps in planning nursing research: From
question to proposal (7th ed.). Sudbury, MA: Jones and Bartlett.
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Appendix A
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Appendix B
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Appendix C
The Confusion Assessment Method Instrument:
1. [Acute Onset] Is there evidence of an acute change in mental status from the patient’s baseline?
2A. [Inattention] Did the patient have difficulty focusing attention, for example, being easily distractible, or having
difficulty keeping track of what was being said?
2B. (If present or abnormal) Did this behavior fluctuate during the interview, that is, tend to come and go or
increase and decrease in severity?
3. [Disorganized thinking] Was the patient’s thinking disorganized or incoherent, such as rambling or irrelevant
conversation, unclear or illogical flow of ideas, or unpredictable switching from subject to subject?
4. [Altered level of consciousness] .Overall, how would you rate this patient’s level of consciousness? (Alert
[normal]; Vigilant [hyperalert, overly sensitive to environmental stimuli, startled very easily], Lethargic [drowsy,
easily aroused]; Stupor [difficult to arouse]; Coma; [unarousable]; Uncertain)
5. [Disorientation] Was the patient disoriented at any time during the interview, such as thinking that he or she was
somewhere other than the hospital, using the wrong bed, or misjudging the time of day?
6. [Memory impairment] Did the patient demonstrate any memory problems during the interview, such as inability
to remember events in the hospital or difficulty remembering instructions?
7. [Perceptual disturbances] Did the patient have any evidence of perceptual disturbances, for example,
hallucinations, illusions or misinterpretations (such as thinking something was moving when it was not)?
8A. [Psychomotor agitation] At any time during the interview did the patient have an unusually increased level of
motor activity such as restlessness, picking at bedclothes, tapping fingers or making frequent sudden changes of
position?
8B. [Psychomotor retardation].At any time during the interview did the patient have an unusually decreased level
of motor activity such as sluggishness, staring into space, staying in one position for a long time or moving very
slowly?
9. [Altered sleep-wake cycle]. Did the patient have evidence of disturbance of the sleep-wake cycle, such as
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excessive daytime sleepiness with insomnia at night?
The Confusion Assessment Method (CAM) Diagnostic Algorithm
Feature 1: Acute Onset and Fluctuating Course
This feature is usually obtained from a family member or nurse and is shown by positive responses to the following
questions: Is there evidence of an acute change in mental status from the patient’s baseline? Did the (abnormal)
behavior fluctuate during the day, that is, tend to come and go, or increase and decrease in severity?
Feature 2: Inattention
This feature is shown by a positive response to the following question: Did the patient have difficulty focusing
attention, for example, being easily distractible, or having difficulty keeping track of what was being said?
Feature 3: Disorganized thinking
This feature is shown by a positive response to the following question: Was the patient’s thinking disorganized or
incoherent, such as rambling or irrelevant conversation, unclear or illogical flow of ideas, or unpredictable switching
from subject to subject?
Feature 4: Altered Level of consciousness
This feature is shown by any answer other than “alert” to the following question:
Overall, how would you rate this patient’s level of consciousness? (alert [normal]), vigilant [hyperalert], lethargic
[drowsy, easily aroused], stupor [difficult to arouse], or coma [unarousable])
The diagnosis of delirium by CAM requires the presence of features 1 and 2 and either 3 or 4.
CAM Instrument and Algorithim adapted from Inouye, S., van Dyck, C., Alessi, C., Balkin, S., Siegal, A. &Horwitz,
R.(1990). Clarifying confusion: the confusion assessment method. Annals of Internal Medicine, 113(12), 941-948.