A recent correspondence letter (CJ Black, AC Ford. AJG 2020; doi: 10.14309/ajg.0000000000000932. Full text: Efficacy of Ondansetron for Irritable Bowel Syndrome With Diarrhea) shows that ondansetron could be an effective option for irritable bowel syndrome with diarrhea. Thanks to Ben Gold for this reference.
In the current trial, 120 adult ED patients with nausea or vomiting who did not require intravenous access were randomized to inhaled isopropyl alcohol plus 4 mg oral ondansetron; inhaled isopropyl alcohol plus oral placebo; or inhaled saline plus 4 mg oral ondansetron. Isopropyl alcohol was provided in the form of a standard alcohol swab. Patients received a single dose of the oral intervention but could sniff alcohol or saline swabs repeatedly. Nausea was measured on a 100-mm visual analog scale at baseline and 30 minutes.
Mean nausea scores decreased by 30 mm in the alcohol/ondansetron group, 32 mm in the alcohol/placebo group, and 9 mm in the saline/ondansetron group. Rescue antiemetic therapy was given to 28%, 25%, and 45% of each group, respectively. Differences between alcohol and saline groups were statistically significant. Patients in the inhaled alcohol groups also had better nausea control at the time of discharge and reported higher satisfaction with nausea treatment. No adverse events occurred. The mechanism of action is currently unknown.
Dr. Pallin’s comments on study:
It is uncommon for us to assign a rating of “Practice Changing” to a small, single-center study, but these results are truly remarkable and are consistent with prior research. For patients not obviously requiring IV therapy, we should treat nausea with repeated inhalations from an isopropyl alcohol swab instead of administering any other drug. And, although this study provides no direct evidence of benefit to patients who do require IV therapy, there would seem to be little downside to trying this simple and safe intervention in that group, too.
My take: Who is doing the pediatric study to try to replicate these results in the pediatric population?
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Another study (AS Danewa et al J Pediatr 2016; 169: 105-9) has shown that ondansetron (zofran) is effective for gastroenteritis. In children (n=170) between 3 months and 5 years with acute diarrhea and vomiting in India, a single dose of ondansetron (0.2 mg/kg) syrup prior to the use of oral rehydration therapy (ORT) improved outcomes.
Failure of ORT was 31% in those treated with ondansetron compared with 62% given placebo (P<.001). there was fewer vomiting episodes and lower rates of IVF usage in those who received ondansetron.
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Briefly noted: A selected summary (Gastroenterol 2014; 147: 527-28) reviews the potential utility of ondansetron (median dose in adult participants was 4 mg) for irritable bowel syndrome with diarrhea (IBS-D) based on a recent study (Link to full online journal article: Randomized Trial of Ondansetron for IBS-D in Gut).
Several limitations are discussed including patient dropout, crossover study design, and short term study (in chronic disease). As such, even though this study provides some evidence that ondansetron may be helpful for IBS-D, this probably needs “to be replicated in large-scale, parallel group, randomized, placebo-controlled trials…with longer duration of therapy..before the true place of ondansetron in the management of IBS-D is known.”
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A recent study indicates that a single oral dose of ondansetron (Zofran®) is safe.
This excerpt from Eric Benchimol’s twitter feed: ow.ly/rBaV0:
New research from The Hospital for Sick Children (SickKids) and the University of Calgary’s Alberta Children’s Hospital Research Institute helps to clarify the actual risk of ondansetron administration and cardiac arrhythmias in both children and adults. The study is published in the December issue of Annals of Emergency Medicine.
In 2011, the Food and Drug Administration notified health-care professionals and patients of an ongoing safety review and labelling changes for the anti-nausea drug linking its use to the possibility of inducing abnormal and potentially fatal arrhythmias. The warning also implied that doctors needed to rule out conditions that might place patients at risk for developing an abnormal heart rhythm prior to giving patients the drug. Screening all patients for such conditions requires ECG monitoring and blood testing, which are associated with discomfort, delayed care and may lead to additional unnecessary investigations and anxiety. In 2012, the FDA issued an update linking the risk only to the administration of the drug in high doses intravenously. However, there was no change in the universal screening recommendations to all patients before receiving ondansetron, in any dose or route…
Through an in-depth post-marketing analysis which included a systematic review of published literature, the FDA Adverse Events Reporting System and the World Health Organization Individual Safety Case Reports Database, Drs. Yaron Finkelstein and Stephen Freedman explored this association. They did not find any reports of arrhythmia related to the administration of a single oral dose of ondansetron, the most common administration route, employed in over 85 per cent of doses given to children in emergency departments…
The study’s principal investigator, Dr. Yaron Finkelstein, staff physician in Paediatric Emergency Medicine and Clinical Pharmacology and Toxicology and Associate Scientist at SickKids. “Despite more than 22 years of use and hundreds of millions of ondansetron doses administered worldwide, we did not find evidence to support screening of patients without known risk factors before administering a single oral ondansetron dose.”
Bottomline: “The authors concluded that ECG screening and electrolyte testing should be targeted to patients with known risk factors such as patients with cardiac diseases or those concomitantly receiving other arrhythmia-inducing medications and those receiving ondansetron intravenously or repeated doses, while it is not warranted in low-risk individuals who are receiving a single oral dose.”
Related blog post: A drug that makes a difference: ondansetron | gutsandgrowth
Ondansetron (Zofran ®) use has become more common and is making a difference (JPGN 2012; 54: 381-86). This drug has been a terrific advance for so many individuals with disorders that provoke vomiting and nausea. Not only does it have a high degree of effectiveness, but side effects are also quite uncommon.
The cited study documents ondansetron’s increasing use in Toronto. This retrospective cohort study of children younger than 18 years with gastroenteritis examined emergency room visits between 2003 and 2008. 20% of 22,125 charts were selected randomly for review (n=3508 patients in final analysis). During the study period, intravenous rehydration decreased from 27% to 13% and ondansetron use increased from 1% to 18%. Associated with ondansetron use, mean length of stay decreased from 8.6 to 5.9 hours. Also, the week following the index visit, there was a reduction in return visits from 18% to 13% as well as decreased need for intravenous rehydration (7% to 4%).
The authors state that analysis elsewhere has indicated that appropriate usage of ondansetron for this indication could result in savings of more than $65 million each year in the U.S. The main limitation of this study is that other factors could have changed during the study period and resulted in some of these improvements; though, this institution did not have any major changes which could be identified.
Of course, ondansetron is used in many other clinical settings besides the emergency room. Though the drug is expensive, it is worth the cost.
- -Arch Pediatr Adolesc Med 2008; 162: 858-65. Use of antiemetic agents in AGE.
- -Ann Emerg Med 2008; 52: 22e6-9e6. Use of oral ondansetron in children with AGE who failed oral rehydration.
- -NEJM 2006; 354: 1698. Use of zofran did not decrease hospitalization but did decrease need for IV fluids and decreased vomiting.