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

P>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 enrolment. 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.