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

Aliment Pharmacol Ther. 2010 Jan;31(1):82-91. doi: 10.1111/j.1365-2036.2009.04145.x.

Abstract

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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Administration, Oral
  • Child, Preschool
  • Double-Blind Method
  • Female
  • Fluid Therapy / methods
  • Gastroenteritis / complications
  • Gastroenteritis / drug therapy*
  • Humans
  • Male
  • Ondansetron / administration & dosage*
  • Ondansetron / adverse effects
  • Treatment Outcome
  • Vomiting / drug therapy*
  • Vomiting / etiology

Substances

  • Ondansetron