Single-dose Intravenous Ondansetron in Children with Gastroenteritis: A Randomized Controlled Trial
Abstract
OBJECTIVE: To evaluate the efficacy of ondansetron for the treatment of vomiting and thus reducing the need for intravenous (IV) rehydration in children with gastroenteritis.
DESIGN: Double-blind, placebo-controlled, randomized trial.
SETTING: Pediatric ward of An Giang General Hospital, South Vietnam, between December 2013 and June 2014.
PARTICIPANTS: 61 inpatient children (age 11-60 mo) suffering from gastroenteritis with vomiting. Exclusion criteria were: underlying chronic conditions, immunodeficiency, malnutrition or history of allergy to ondansetron.
INTERVENTION: Single bolus of IV ondansetron at a dose of 0.2 mg/kg or placebo.
OUTCOME MEASURES: Proportion of patients who needed IV rehydration, proportion of patients with cessation of vomiting, amount of oral rehydration solution intake, duration of diarrhea and the length of hospital stay.
RESULTS: After drug administration, 22 (73%) of the 30 patients in the ondansetron group had complete cessation of vomiting compared with 7 (23%) of the 31 patients in the placebo group (RR 0.32; 95% CI 0.16 to 0.63, P<0.001). 3 (10%) patients in the ondansetron group required IV rehydration as compared with 12 (39%) in the placebo group (RR 0.51; 95% CI 0.33 to 0.79, P=0.009). The median amount of oral rehydration solution intake in 24 hours was significantly greater in the ondansetron group (450 mL vs 350 mL, P=0.019).The duration of diarrhea and the length of hospital stay were not different between the two groups.
CONCLUSIONS:…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 61 participants or records.
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