Freedman SB, et al. N Engl J Med. 2025 Jul 17;393(3):255-266. doi: 10.1056/NEJMoa2503596.
Methodology: 4.5/5
Usefulness: 4/5
Question and Methods: This multicentre, double-blind randomized superiority trial evaluated the effectiveness of oral ondansetron dispensed at discharge compared to placebo in pediatric patients discharged from the emergency department (ED) with acute gastroenteritis.
Findings: For the primary outcome of moderate to severe gastroenteritis within 7 days of enrollment as defined by a modified Vesikari score of 9 or more, ondansetron was superior to placebo (5.1 % in the ondansetron group and 12.5% in the placebo group), with an unadjusted risk difference of -7.4%. Despite a small increase of diarrheal stools in a subset of participants who received at least three doses of ondansetron, adverse effects were similar between groups.
Limitations: One limitation of this study is the potential for recall bias due to caregiver surveys not being administered daily.
Interpretation: In pediatric patients presenting with acute gastroenteritis vomiting, the provision of a small number of doses of ondansetron has been shown to be safe and effective for improving symptoms of gastroenteritis in the seven days following ED discharge.
JC Supervisor: Dr. Krishan Yadav
