Joyce S. Willens, PhD, RN, BC
Villanova University
History of EBG
 Existed in clinical practice for decades
 Called Practice Guidelines
 Practice Policies
 Clinical Policies
 Clinical Algorithms
 Position Statements
History
 Movement began in US in the mid 1980s
 National Institute of Health came under pressure from
policy makers to provide formal system of assessing
new medical developments
 Evolved into NIH Consensus Development
Experience with EB Guidelines
Reviewed pain
literature
All neuraxial opioid
studies
AHCPR- 1992
Experience with EB Guidelines
Reviewed ALL
literature for these
guidelines
APS - 1994
Sickle Cell Pain Guidelines
 Computer data bases used to search literature
beginning in 1965
 Key words pain and sickle cell anemia
 Inclusion criteria were:
 Research articles including assessment and
measurement
 Pain guidelines and management articles
Presented “State of the Art”
 Cardiology conference
 2000
 Tel Aviv, Israel
Presentation given in Tel Aviv Israel in 1990
Clinical Practice Guidelines
 Systematically developed statements to
assist practitioner and patient decisions
about appropriate health care for specific
clinical conditions (Institute of Medicine).
Process
 Developed levels of scientific evidence
 Developed strength and consistency of evidence
 A- type 1 or consistent findings from multiple study
types
 B – evidence of types II, III, or IV but findings are
inconsistent
Currently -Identify the Problem
 Began with noticing > use of naloxone
 Tracking by nurses and pharmacists
 Commonality IV PCA
 Incidence of sudden onset life-threatening respiratory
event with IV opioid analgesia is 3.6 per 10,000 adults
Comprehensive Literature Review
 There were no universally accepted guidelines to direct
effective and safe assessment and monitoring
practices.
 Research has not firmly established that measuring
SpO2 and capnography (ETCO2) prevents mortality
ASPMN Expert Consensus Panel
 Led by Donna Jarzyna, MS, RN-BC, CNS-BC
 Carla R. Jungquist, PhD, RN-C, FNP
 Chris Pasero, MD, RN-BC, FAAN
 Allison Nisbet, MSN, RN, CPHON, AOCNS, CNS-BC
 Linda Oakes, MSN, RN-BC, CCNS
 Susan J. Dempsey, MN,RN-BC, CNS
 Diane Santangelo, MS, RN, ANP-C
 Rosemary C. Polomano, PhD, RN, FAAN
 Convened in April 2008
Monitoring
 Defined – practice of using the nurse observations of
sedation and respiration including but not limited to
the use of sedation assessment scales and technologies
to collect serial measurement to anticipate and
recognize unintended advancing sedation or
respiratory depression.
Step 1
 Panel members independently searched electronic
databases
 Medline
 PubMed
 Cumulative Index to Nursing and Allied Health
Literature (CINAHL)
 Cochrane Library
Relevant Publications
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Data based articles
Case reports
Clinical Reviews commentaries and editorials
Terms – opioid induced sedation and respiratory
depression
 > 50 citations were on black board for
review
 Tele conferences were held to discuss
the readings
Step 2
 17 articles of varying quality were selected
 Each panel member independently rated at least 3



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articles
Scope of content
Overall quality
Adequacy of references
Evidence of research synthesis
Confirmation of existing evidence and research
Relevance to practice
Cohen’s Kappa Statistic
 Calculated percent agreement
 0.72- 1.00
 High degree of concordance among raters
Consensus on categories for
evidence
 Individual Patient Risks
 Iatrogenic Risks
 Pharmacology
 Monitoring
Literature Included
 Meta-analysis
 Systematic reviews
 Randomized controlled trials (RCT)
 Clinical Trials
 Prospective observational studies
 Retrospective reviews
 Secondary analyses
Opinion Based Data
 Survey members to conduct practice analysis
 Use of monitoring when pt receiving opioids
 On-line survey January 2009-end of February
 These results have been published in 2011
 Conducted the survey again in 2013
 Published in September issue 2014
ASA Grading System
 Originally used by an ASA taskforce for their report on
operating room fires
 Class I – Normally healthy
 Class II- Patient with mild systemic disease
 Class III- Patient with severe systemic disease
 Class IV- Patient with severe systemic disease that is a
threat to life
 Class V- Morbid patient who is not expected to survive
without the surgery
 Class VI- A declared brain- dead patient for organ
removal
Strength of Evidence and Benefit
Risk Ratio
 ACC/AHA Taskforce on Practice Guidelines (2010)
 Class I. Evidence and/or general agreement that a
given treatment is useful and effective
 Benefit>>> Risk
 Class II. Conflicting evidence and/or a divergence of
opinion about the usefulness/efficacy of treatment
Strength of Evidence and Benefit
Risk Ratio
 Class II. Conflicting evidence and/or a divergence of
opinion about the usefulness/efficacy of treatment
 Class IIa-. Weight of evidence/opinion is in favor of
usefulness

Benefit >>Risk
 Class IIb. Usefulness/efficacy is less well established by
the evidence
 Benefit > Risk
Strength of Evidence and Benefit
Risk Ratio
 Class III. Conditions for which there is evidence
and/or general agreement that the treatment is not
useful and in some cases may be harmful
 Risk > Benefit
 ACCF/AHA Taskforce on Practice Guidelines.
Methodology Manual for ACCF/AHA Guideline
Writing Committees
 http://my.americanherat.org.idc/groups/ahamahpubli
c/@wcm/@sop/documents/downloadable//ic,_319826
/pdf
Statement of Conditions
 Aligned with ASPMN mission and goals
 Serves as a guide for developing and implementing
safe and effective plans of care
 Facilitates systems-level changes
 Applies scientifically derived and consensus based
among panel members
 No pharmaceutical involvement
Individual Risks
 Factors that predispose a person to unintended opioid-
induced advancing sedation and respiratory
depression
 Not limited to
 Age
 Anatomic anomalies
 Physical characteristics
 Primary and comorbid medical condition
 Psychologic states
 Functional status
Patient Risk Factors
 Two categories
 Sleep disordered breathing – B-1 evidence
 Postoperative pulmonary complications

B-1 evidence
Sleep disordered Breathing
 Factors that predispose a person to unintended opioid-
induced advancing sedation and respiratory
depression.
Sleep Disordered Breathing
 Keywords: sleep apnea- 7,647 citations
 Risk factors- 436,675 citations
 Combined with the word and
 1639 citations
 91 were deemed relevant
Postoperative Pulmonary
Complications
 Postoperative complications
 11,861 citations
 Risks
 180,339 citations
 Combined using and- 521 citations
 68 were deemed relevant
Other Categories
 Iatrogenic Risks with Pain Treatment Modalities
 Supplemental Opioids with Peripheral Local
Anesthetic Agents
 Parenteral, Subcutaneous, and Patient Controlled
Analgesia
 Coadministration of Antihistamines
 Coadministration of Benzodiazepines
Other Categories
 Timing as a Predictor for Opioid-Induced Sedation
and Respiratory Depression
 Categories B-1 and B-2 Evidence
 Communication
 Not much in literature
 Support for SBAR
Categories
 Pharmacology- pharmacologic agents that are
administered for the treatment of pain in the acute
care setting
 Comparison of Opioid Analgesics – Category C-2

NS difference in respiratory depression between opioids
 Acetaminophen- Category A-1 Evidence
 NSAIDs – Category A-1 Evidence
Categories
 Anticonvulsants – Category A-1 Evidence for Sedation
 Antidepressants- Category D- Insufficient Evidence
 Clonidine- Category C-2 Evidence
 Ketamine-Category C-2 Evidence
 Dexmedetomidine- Category C-2 Evidence
Categories
 Patient Monitoring Practices
 Opioid –Induced Sedation
 Sedation Scales
 Opioid-induced Respiratory Depression
 Technology Supported Monitoring
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Use of pulse oximetry
Use of capnography
After Each Category
 Recommendation Statements for each category
 Statements for each category


Should, is recommended, is indicated, is
useful/effective/beneficial
Unknown/unclear/uncertain/not well established
 Recommendations for Education
 Implementation Strategies
Finished Document
 Sent out for external review by 10 experts
 Pain Management Nurses
 Pharm D
 Anesthesiologists
Presentations
 Jungquist, C.R. & Willens, J.S. Preventing adverse
events secondary to opioid-induced advancing
sedation and respiratory depression in adult
hospitalized patients: Evidence to bedside- American
Pain Society-Honolulu, HI May 2012
Presentations
 Jungquist, C.R. & Willens, J.S. Preventing adverse
events secondary to opioid-induced advancing
sedation and respiratory depression in adult
hospitalized patients: Evidence to bedside- American
Society for Pain Management Nursing- Baltimore, MD
September 2012
Monitoring for Opioid Induced
Sedation and Respiratory
Depression- 2nd survey 2013
 Asked whether their hospital was practicing 4 safety
procedures
 Written guidelines for assessment after opioid initiation
or titration
 Double- check of PCA when initiating, titrating or
inserting new PCA
 Two person check of epidural drug/programing as above
 Bar code medication administration
Monitoring for Opioid Induced Sedation and Respiratory
Depression- 2nd survey 2013
 ASPMN members invited via email
 June 2013 noted 102 hospitals responded
 Practice changes over time
 Written guidelines for assessment after opioid
initiation/titration
86% 2013 vs. 90% in 2009
 Double check of PCA program, initiation, titrating or
hanging new bag
 96% vs 96%
 2 person check of epidural drugs/programming 80% vs.
86%
 Bar code med administration 65% vs 30%
Pulse Oximetry Monitoring
 28% of institutions represented in this survey use
continuous pulse oximetry
 2% reported they did not know their institution’s
practices or do not use electronic monitoring at all
 Over the last 4 years the use of pulse ox has increased
 The use of end tidal CO2 monitoring has increased
from 2% to 11%
Sedation Scales
 All institutions reported using some type of sedation scale
 90% of nurses endorsed assigning numbers to a level of
sedation
 Results of the survey indicate that changes in practice are
occurring
Frequency of screening for high risk-OSA
Authorized agent controlled analgesia
Criteria for defining respiratory depression
Hired or trained a “expert pain nurse”
Initiated or refined order sets for PCA
Changed from intermittent to continuous pulse ox
monitoring
 Implemented use of sedation scale
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Pasero Opioid-Induced Sedation
Scale with Interventions
S= Sleep; easy to arouse
action necessary
No
 1. Awake and alert
No action necessary may > opioid
 2. Slightly drowsy, easily arouse No action necessary may
>
 3. Frequently drowsy, arousable, drifts off to sleep during
conversation- Unacceptable- monitor resp and sedation
levels
 < opioid dose 25 -50%
 Consider administration of opioid-sparing nonopioid
 4. Somnolent, minimal or no response to verbal or physical
stim
 Unacceptable; stop opioid; consider administering naloxone
Respiratory Assessment
 More than measuring rate for 30 -60 seconds
 Depth and regularity of respirations
 Notice trends
 Listen to sound of patient’s respiration
 Snoring indicates airway obstruction
 Decrease dose 25%- 50%
 Consider continuous ETCO2 monitoring
Clinical Signs of OSA
 Frequent, loud snoring
 Neck circumference > 17” man- 16” woman
 BMI of 35 kg/m2 or more
Physical Exam
 Awake, alert, oriented
 Appears quite ill and uncomfortable
 One episode of emesis
 VS 98.2, 85, 18, 148/88
 Pain intensity rating 10 on a 0 to 10 scale
Chronology of Treatment
 Admitted to ER at 5:37 PM
 5:50 PM given hydromorphone 1 mg IV
 6:19 PM same
 6:40 PM evaluated by MD
 6:50 PM hydromorphone 1 mg IV
 7:21 PM fentanyl 100 mcg IV
 7:25 PM fentanyl 100 mcg IV
 7:30 PM fentanyl 50 mcg IV- Pain 10/10
 7:40 PM fentanyl 25 mcg IV
Chronology of Treatment
 10:00 PM promethazine 12.5 mg IV and MSO4 5mg IV
 10:25 PM Respiratory therapist called for BIPAP
 PMH of multiple apneic episodes after analgesia
 10:30 PM placed on BIPAP
 11:15 PM promethazine 12.5 plus MSO4 5mg IV
 Next day 00:15 AM
 Desaturation noted
 BIPAP reapplied
Medical Floor
 2:10 AM PCA is begun
 9:50 AM emesis- zophran given - pain 10/10
 11:17 AM MD consult- awake, alert & oriented
 Pain consultation –NP
 PCA changed to 2 mg MSO4 per dose every 15 minutes
with no dose limit
 4:00 PM alert and oriented
 Pt chart for SPO2 left blank
 5:45-9:37 PM – multiple blanks on pt record
 9:37 lorazepam 1 mg IV given for agitation and anxiety
 Removing BIPAP mask, climbing out of bed
 NOTE THE MD WAS NOT CALLED PRIOR TO
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ADMINISTRATION OF LORAZEPAM
10:33 PM Code Blue called
10:54 Narcan 0.8 mg IV
Pulseless electrical activity
Revived but never regained consciousness
Died a year later
 Did not have ETCO2 monitoring on the floor
 NEVER did an arterial blood gas analysis
 Settled out of court