Clinical trial: Oral ondansetron for reducing vomiting secondary to acute gastroenteritis in children - a double-blind randomised study.
Author(s): Yilmaz HL, Yildizdas RD, Sertdemir Y
Affiliation(s): Medical School of Cukurova University, Department of Pediatric Emergency Medicine, Adana, TURKEY.
Publication date & source: 2009-09-16, Aliment Pharmacol Ther., [Epub ahead of print]
Summary Background: Vomiting due to gastroenteritis frequently occurs in children. It is still debatable whether vomiting should be treated with antiemetic drugs. Aim: to investigate potential beneficial effects of ondansetron in treating vomiting during acute gastroenteritis. Methods: A randomized, double blind, placebo-controlled trial was performed in our emergency departments. Children, aged 5 months to 8 years, were randomized to receive either ondansetron tablets or placebo. The primary outcome measure was the frequency of emesis during an 8 hour-period after enrollment. Results: A hundred and nine patients were enrolled; 54 received placebo and 55 received ondansetron. As compared with the children who received placebo, children who received ondansetron were less likely to vomit both during the first 8 hour follow-up in the emergency department [relative risk (RR): 0.33, 95% CI: 0.19-0.56, NNT: 2, 95% CI: 1.6-3.5], and during the next 24 hours follow-up (RR: 0.15, 95% CI: 0.07-0.33, NNT: 2, 95% CI: 1.3-2.1). Conclusion: Ondansetron may be an effective and efficient treatment that reduces the incidence of vomiting from gastroenteritis during both the first 8 hours and the next 24 hours, and is probably a useful adjunct to oral rehydration.