Single-dose Intravenous Ondansetron in Children with Gastroenteritis: A Randomized Controlled Trial

ABSTRACT

Objective: To evaluate the efficacy of ondansetron for thetreatment 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, SouthVietnam, between December 2013 and June 2014.Participants: 61 inpatient children (age 11-60 mo) suffering fromgastroenteritis with vomiting. Exclusion criteria were underlyingchronic conditions, immunodeficiency, malnutrition or history ofallergy 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 IVrehydration, proportion of patients with cessation of vomiting,amount of oral rehydration solution intake, duration of diarrheaand the length of hospital stay.Results: After drug administration, 22 (73%) of the 30 patients inthe ondansetron group had complete cessation of vomitingcompared 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 inthe ondansetron group required IV rehydration as comparedwith 12 (39%) in the placebo group (RR 0.51; 95% CI 0.33 to0.79, P=0.009). The median amount of oral rehydration solutionintake in 24 hours was significantly greater in the ondansetrongroup (450 mL vs 350 mL, P=0.019).The duration of diarrheaand the length of hospital stay were not different between the twogroups.Conclusion: In hospitalized children having gastro-enteritisassociated with emesis, ondansetron is effective in the cessationof episodes of vomiting and in lowering the rates of IV rehydration,without reducing the duration of diarrhea and hospital stay