Zofran-Research 1
Zofran: A Lifesaver for Nausea and Vomiting
Dustin Wilson
November 26, 2006
Research in Allied Health
East Tennessee State University
Dr. Douglas Masini RPFT, RRT-NPS, FAARC, AE-C
Zofran-Research 2
Abstract: Zofran is a medication that is prescribed to patients to prevent nausea and vomiting.
Zofran, also known as Ondansetron, became available in 1991 and was the first drug specifically
created for chemotherapy patients. Since then, it has been widely used for post surgery and
treatment for nausea with other diseases such as Hepatitis C and irritable bowel syndrome.
Zofran is a 5-HT3 receptor antagonist that blocks chemical receptors in the body to help prevent
nausea and vomiting. Several studies have been evaluated, and the results prove that Zofran is an
effective medication battling nausea and vomiting. I feel this drug is very important in the
medicinal world because nausea and vomiting are side effects that make chemotherapy so hard to
bear for patients. Nausea and vomiting are both truly barriers that stop people from living their
lives. They both make patients extremely tired and depressed, blocking them from living and
performing daily tasks.
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Introduction
Cancer has affected my life in that it has struck members of my family with great force.
My grandparents both died of cancer within a year of each other. My grandmother had
squamous cell carcinoma, which is a very forceful cancer. She went through 2 rounds of
radiation, 1 hand amputation, and 1 surgery in which the lymph nodes of her armpit were
removed. In that surgery a mass was found attached to her chest wall. I took her to her radiation
treatments and saw how hard it was. When I started exploring cancer and the various topics that
surround it, Zofran was suggested to me and as I researched it I immediately found myself very
interested in this “wonder drug”. In most of the studies I researched, it dramatically helped the
nausea and vomiting that patients endured because of chemotherapy, radiation therapy, and
operations. I found that not many people know about this drug and many patients go home
without any medication for nausea and vomiting. This paper investigates what Zofran is, how it
affects patients, how it achieves the prevention of nausea and vomiting, as well as the various
uses of this drug. My intent on this research paper is to inform patients of the many uses for this
drug and to answer the question of whether it really works. I also investigated this question as I
want to continue my education in Radiation Therapy and feel this will help add to my
understanding of cancer as a whole.
Problem Statement
My first research question is how does this drug work? I found that this
medication blocks chemicals in the body such as serotonin to prevent nausea and vomiting. Who
is eligible to take this drug? All ages can take this drug. I feel this is extremely important
because it makes this drug truly universal. Are certain types of chemotherapy more prone to
cause nausea and vomiting than others? Yes, certain chemotherapy agents such as Carmustine,
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Cisplatin, Dactinomycin, and Streptozocin are highly likely to cause nausea and vomiting. It is
important for chemotherapy patients to know the agents, or mixture of agents they will be taking
and the likelihood that they will experience nausea and vomiting. Is Zofran only for nausea and
vomiting? Zofran has been proven to be effective against nausea and vomiting in post surgery
cases as well as other illnesses such as fatigue with Hepatitis C, and controlling and regulating
Irritable Bowl Syndrome.
Review of Literature
According to Boschert (2006), a single oral dose of Zofran significantly reduced
vomiting in children treated in a pediatric emergency room from gastroenteritis and mild-tomoderate dehydration, allowing more children to be rehydrated orally rather than intravenously,
Dr. Stephen B. Freeman reported (p. 46). Boschert (2006) used a prospective, double-blind
study that randomized 215 children ages 6 to 10, to receive a tablet of oral Zofran or placebo.
The tablet was administered by a nurse and was done with physicians and research assistants out
of the room. If the children vomited within 15 minutes of receiving the first dose, they then
received a second dose (p. 46). After 15 minutes, clinicians administered intense oral
rehydration starting at a 1-hour period, and could be continued until the patient was sent home or
admitted. The physician could choose to give intravenous fluids after the first hour or oral
rehydration. By reviewing the patients’ records and conducting phone interviews with the
families 3-7 days later, the investigators assessed how many children vomited during oral
rehydration therapy (p. 46). I think the results show that Zofran really does help nausea and
vomiting. They concluded that only 14% of the 107 children in the Zofran group vomited while
receiving oral rehydration therapy, while 35% of the 107 children in the placebo group vomited
(p. 46). Not only did the number of children vomiting decrease, but the mean number of
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episodes were reduced as well. The mean number of episodes for the Zofran group was 0.18
compared to 0.65 for the placebo group. The Zofran group had more episodes of diarrhea during
the oral rehydration, but the difference was not considered clinically significant (p.46). I think
this study is important to note because it is proven that children as well as adults can use Zofran.
It is also significant to note this study is not based on chemotherapy, but is based on
gastroenteritis. I feel that the uses of this drug are numerous, and do not strictly work on cancer
patients.
Thomas and Rhonda Board (2006) state in the AORN Journal that, “prevention and
treatment of post-operative nausea and vomiting are key patient care issues that greatly affect
comfort and satisfaction with care. While surveying 101 patients, vomiting was ranked higher
than pain as the most undesirable outcome of surgery (p. 209). I can identify with this statement
as nausea and vomiting are more dreadful to me than almost any other kind of sickness. Thomas
and Rhonda Board (2006) state that, “Ondansetron (Zofran) reversibly binds to the 5-[HT.sub.3]
receptor and has a rapid onset of action, with a half-life of 3.5 to 5.5 hours. In post-operative
nausea and vomiting the chemoreceptor trigger zone and nucleus tractus solitarii are stimulated
by increased amounts of circulating chemicals, which leads to the release of serotonin. The
process for triggering nausea and vomiting is complex because stimulation may come from other
pathways. This is why I think Zofran is such a wonderful medication, because in most cases it
reduces nausea and vomiting significantly. It has very positive characteristics such as a rapid
onset, and a reduced dose to the patient. Therefore it is important to note that Zofran has been
found effective at substantially lower doses that those approved by the US Food and Drug
Administration (p. 209).
Jones et. al. (1991) state, “nausea and vomiting are common side effects of cancer
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chemotherapy.” These researchers conducted a multicenter, randomized, double-blind, crossover trial with two treatment periods that are separated by 21 days. They compared the efficacy
and safety of Ondansetron (Zofran) with Dexamethasone. The number of patients entered in the
study was 112. There was no significant difference between the two noted on day one, although
there was significantly less failure with Ondansetron than with Dexamethasone. Severe nausea
on day one was reported by 8% of patients taking Ondansetron and 13% of those taking
Dexamethasone (p 483). Both of these medications were highly effective in controlling nausea
and vomiting. Although, Jones et. al. (1991) noted, “significantly fewer patients taking
Ondansetron reported failure to control emesis”. I feel that this study proves that once again this
medication is very universal in controlling nausea and vomiting no matter what the cause.
Another study done by Maddali et. al, concludes that the use of Dexamethasone in conjunction
with Ondansetron is the optimal treatment for post operative nausea and vomiting after
diagnostic gynecological laparoscopic procedures (p 302). The more research I do, the more
sicknesses and post operations I find that are controlled by Zofran, also known as Ondansetron. I
feel this study proves that this is one of, if not the best drug on the market for nausea and
vomiting especially caused by chemotherapy. This drug is important because when utilized, it
can help curve the nausea and vomiting which are big problems when dealing with
chemotherapy. It can help lighten the very heavy load that cancer patients have to bear.
Viera et. al (2002) state, “irritable bowel syndrome is the most common functional
disorder of the gastrointestinal tract and is frequently treated by family physicians” (p1867).
Although a lot of patients lose sleep over this condition, it is a benign condition. New
medications such as Zofran target neurotransmitter receptors that are located in the
gastrointestinal tract. In the United States, 3.5 million physician visits annually have been
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accounted for my IBS at an estimated cost of 8 billion dollars. Irritable bowel syndrome is the
most common diagnosis in gasteroenterologic practices. I feel that since this medication can
target neurotransmitter receptors that are in the GI tract, it would be a great suggestion for
patients suffering from this condition.
I found a very interesting article about bulimia nervosa. Anne D. Walling (2000) states,
“the disorder usually includes binge eating followed by self-induced vomiting and incorporates a
sense of loss of control over the behavior and distortions of body image” (p 1156). After
recruiting 26 women who suffered from bulimia nervosa, an extensive study was conducted. In
the next few weeks, the women kept a diary of all of their eating and purging events. Walling
(2000) concluded that, “Ondansetron appeared to normalize several aspects of satiation and
control of eating behaviors” (p 1156). I found this study to be amazing because I have very little
knowledge about eating disorders, and never thought that Zofran could help patients suffering
from eating disorders. Another controversial subject is alcoholism. In a study conducted by
Bankole A. Johnson of the University of Texas Science Center, Sarah Ramsay (2000) reported
that, “Ondansetron could be used to treat patients with early onset alcoholism” (p 742). In this
study 271 patients were randomized, with ages ranging from 25 to 65. I feel on one side that it is
great that it can help treat alcoholism, but on the other side I am worried that this will give
alcoholics more of a reason to drink if it only controls nausea and vomiting and doesn’t help
them stop the addiction to alcohol.
E Anthony Jones (1999) states, “a woman with chronic Hepatitis C and profound fatigue
became symptomfree when treated long-term with Ondansetron 4mg twice daily” (p 397). I feel
this is great because it is more than impressive that this medication helps the symptoms of
Hepatitis C. The mechanism of fatigue in patients with this condition is still unknown, but
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altered central serotoninergic neurotransmission may contribute to it. If it is involved, a
medication such as Ondansetron could help (p 397).
Cancer patients not only have to worry about their lives, but they also have to worry
about how to pay for the drugs they need to prevent nausea and vomiting. M. Orme (1991) states,
“Ondansetron may be better than other antiemetics in some patients receiving cancer
chemotherapy, yet even specialist hospitals cannot afford to prescribe it for all those likely to
benefit” (p 593). I feel that this has to change because Ondansetron is a vital part in reducing
nausea and vomiting. In an article by Elizabeth J. Scharman (1998) I found that since
Ondansetron has a higher cost than other antiemetics, it is used as a second line agent for
patients. I feel that since Zofran has a low failure rate, it should be used as a first line agent.
Method
I am conducting this study to prove that when treating children with gastroenteritis,
Zofran reduces nausea and vomiting. I found my participants at the Johnson City Medical
Center Emergency Room. The participants were 215 children, with ages ranging from 6 months
to 10 years old. After gaining parental consent from the guardians of the minors, my study was
reviewed by the ETSU IRB. The HIPPA guidelines were followed in order to protect patient
confidentiality. These guidelines were observed on the ETSU IRB webpage. I would complete
the ETSU IRB CITI training and would need approval from the doctors and nurses in the
emergency room as well as consent once again from the guardians of the minors. To observe an
accurate model, I replicated a study found in my review of literature. The information came
from an article by Sherry Boschert published in Pediatric News. My study is parametric with an
interest in the difference between two groups. My experiment is parametric because my sample
population has known statistical properties. The two groups taking part in this study are the
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children receiving Zofran and the children receiving the placebo. Since there are two groups, I
will assess the results using a t-test for independent samples. The t-test will be used to in order
to accurately assess the difference in the effect of the placebo and Zofran. I would use inferential
statistics to determine if Zofran actually did have an effect on nausea and vomiting or if it
happened by chance. Reliability is an important factor in this study because in order for the
medication to be reliable, similar findings need to be found if the study is replicated. Since this
is a true experimental design, manipulation, control, and randomization are all parts of this study.
This design allows me to determine if Zofran is an effective treatment. This was a prospective,
double-blind study in which the 215 children received a tablet of oral Zofran or a placebo
administered by a nurse. The children that vomited within 15 minutes received a second dose of
Zofran. After those 15 minutes, an intense 1-hour period of intense oral rehydration was
administered to reduce dehydration. The rehydration could be continued until the patient was
sent home or admitted. The assessment was made on how many children vomited during
rehydration therapy 3 to 5 days later. This assessment was achieved by conducting phone
interviews with the families and reviewing the patient records. The results show that 14 percent
of the 107 children in the Zofran group vomited during the therapy, compared to 35 percent of
the 107 children in the placebo group. One child in the Zofran group was no included because
parental consent could not be obtained before randomization. The mean number of episodes of
vomiting was 0.18 for Zofran and 0.65 for the placebo. By comparing the Zofran group to the
placebo group, I can accurately conclude that Zofran is effective against nausea and vomiting
when treating gastroenteritis in children.
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Discussion
I feel my findings show that Zofran (Ondansetron) is an effective medication when
reducing nausea and vomiting with an array of illnesses. When speaking to friends and family
about this drug, they all revealed that this drug sounds very important when dealing with nausea
and vomiting. They all also discussed how nausea and vomiting are two things they never like to
deal with, so this medication is something everyone should know about. I was amazed at how
much I found on this medication. It has been proven to be effective for use against so many
conditions even for eating disorders and alcoholism. I found that in some cases, Zofran could be
used in conjunction with Dexamethasone for optimal treatment. I feel this was an important
finding because if this medication cannot be used for relief of nausea and vomiting by itself, it
can be added with other medications for treatment, making this medication very flexible. As
with most medications, Zofran is also expensive and although some people need it, they cannot
afford it. This subject needs to be addressed immediately because although a medication could
help save lives, it could be out of patients’ reach.
Conclusion
My problem statement is: How does this drug work? I found that this drug blocks
chemicals in the body to prevent nausea and vomiting. When researching, the number of
illnesses this drug helps is astonishing. I found that it helps patients dealing with gastroenteritis,
Hepatitis C, cancer treatment therapy, bulimia nervosa, and alcoholism. I feel that a new
direction could be researching for a way to help this drug reach more patients. I feel that the
question of why patients do not receive Zofran for nausea and vomiting should be the problem
statement of that research. In summary, I have found that Zofran is an effective medication for
treatment of nausea and vomiting for patients dealing with various illnesses.
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References
Boschert, Sherry. (July 2006) Zofran reduces vomiting, aids oral rehydration. In Pediatric
News, 40, p46(1). Retrieved November 6, 2006, from InfoTrac OneFile via Thomson
Gale.
Board, Thomas, & Board, Rhonda. (Jan 2006) The role of 5-H[T.sub.3] receptor antagonists in
preventing: postoperative nausea and vomiting. In AORN Journal, 83, p209(9).
Retrieved November 13, 2006, from InfoTrac OneFile via Thomson Gale.
Jones, Alison L., Hill, Andrea S., Soukop, Michael, Hutcheon, Andrew W., Cassidy, James,
Kaye, Stanley B., Sikora, Karol, Carney, Desmond N., & Cunningham, David. (August
24, 1991) Comparison of dexamethasone and ondansetron in the prophylaxis of emesis
induced by moderately emetogenic chemotherapy. In The Lancet, 338, p483(5).
Retrieved November 13, 2006, from InfoTrac OneFile via Thomson Gale.
Jones, E Anthony. (July 31, 1999) Relief from profound fatigue associated with chronic liver
disease by long-term ondansetron therapy. (Research Letters)(Statistical Data Included).
In The Lancet, 354, p397. Retrieved November 21, 2006, from InfoTrac OneFile via
Thomson Gale.
Maddali, M.M., Mathhew J., Fahr, J., & Zarroug, A.W. (Oct-Dec 2003) Postoperative nausea
and vomiting in diagnostic gynaecologicai laparoscopic procedures: comparison of the
efficacy of the combination of dexamethasone and metoclopramide with that of
dexamethasone and ondansetron. (Original Article). In Journal of Postgraduate
Medicine, 49, p302(5). Retrieved November 21, 2006, from InfoTrac OneFile via
Thomson Gale.
Orme, M. (Sept 14, 1991) How to pay for expensive drugs. (Pitting hospitals against general
practices is not the answer.) (editorial). In British Medical Journal, 303, p593(2).
Retrieved November 21, 2006, from InfoTrac OneFile via Thomson Gale.
Ramsay, Sarah. (August 26, 2000) Ondansetron to treat early-onset alcoholism? (News)(Brief
Article). In The Lancet, 356, p742. Retrieved November 21, 2006, from InfoTrac
OneFile via Thomson Gale.
Scharman, Elizabeth J. (Jan-March 1998) Use of ondansetron and other antiemetics in the
management of toxic acetaminophen ingestions. In Journal of Toxicology: Clinical
Toxicology, 36, p19(7). Retrieved November 21, 2006, from InfoTrac OneFile via
Thomson Gale.
Viera, Anthony J., Hoag, Steve, & Shaughnessy, Joseph. (Nov 15, 2002) Management of
irritable bowel syndrome. (Cover Article Practical Therapeutics). In American Family
Physician, 66, p1867. Retrieved November 13, 2006, from InfoTrac OneFile via
Thomson Gale.
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Walling, Anne D. (Sept 1, 2000) Antinausea Drug Promising in Treatment of Bulimia
Nervosa. (Brief Article). In American Family Physician, 62, p1156. Retrieved November
21, 2006, from InfoTrac OneFile via Thomson Gale.