Abstract Objective: To compare the efficacy and safety of ondansetron versus metoclopramide in the treatment of vomiting for acute gastroenteritis in the prehospital setting. Study design: This was a double-blind trial including consecutive patients aged between 1-14 years treated in an urban urgent care setting. A total of 167 children were randomized to receive a single dose of intravenous ondansetron or metoclopramide. The primary efficacy outcome was the proportion of patients with cessation of vomiting right after completion of the study medication infusion in each group. Observed side effects, diarrhea frequency in admission and follow up were recorded to assess safety. Results: A total of 167 previously healthy children (median age, 3 years) diagnosed with acute gastroenteritis with persistent vomiting completed treatment and observation. Cessation of vomiting was achieved in 68/84 patients (81%) of the ondansetron, and 60/83 (72%) of the metoclopramide groups, P=0.14. Mean time to complete cessation of vomiting was 39 min (SD111) for ondansetron, and 61 min (SD110) for metoclopramide groups, P= 0.2. The mean length of hospital stay was 550 min (SD 427) for ondansetron, and 575 min (SD 449) for metoclopramide groups, P=0.71. Revisits rate, readmissions rate and frequency of diarrhea after discharge were similar in the 2 treatment groups. No adverse reaction or other safety concerns were identified. Conclusions: Intravenous metoclopramide is effective and might be considered a safe alternative to ondansetron in the treatment of persistent vomiting for children with gastroenteritis admitted for intravenous fluid hydration.


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