Clinical trial: oral ondansetron for reducing vomiting secondary to acute gastroenteritis in children--a double-blind randomized study.

Author(s): Yilmaz HL, Yildizdas RD, Sertdemir Y.

Affiliation(s): Department of Pediatric Emergency Medicine, Medical School of Cukurova University, Adana, Turkey. hyilmaz@cu.edu.tr

Publication date & source: 2010, Aliment Pharmacol Ther. , 31(1):82-91

BACKGROUND: Vomiting as a consequence of 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 0.2 mg/kg or placebo at 8h intervals. The primary outcome measure was the frequency of emesis during an 8-h-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-h 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-h 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 h and the next 24 h, and is probably a useful adjunct to oral rehydration.