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Ondansetron dosing in pediatric gastroenteritis: a prospective cohort, dose-response study
Stephen B Freedman1, Elizabeth C Powell, Alejandro A Nava-Ocampo
1Division of Pediatric Emergency Medicine, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.
Insights
Higher doses of oral ondansetron (0.13-0.26 mg/kg) did not improve efficacy or increase side effects in children with gastroenteritis. The study found similar outcomes for vomiting, rehydration, and hospitalization across the tested ondansetron dosage range.
Area of Science:
- Pediatric Gastroenterology
- Clinical Pharmacology
- Emergency Medicine
Background:
- Ondansetron is frequently used for pediatric acute gastroenteritis-related emesis.
- The optimal ondansetron dosage for this population remains undetermined.
Purpose of the Study:
- To assess the efficacy and safety of higher oral ondansetron doses in children with gastroenteritis.
- To identify any dose-dependent side effects of ondansetron in this pediatric cohort.
Main Methods:
- Prospective analysis of 105 children (0.5-8.2 years) receiving oral ondansetron (0.13-0.26 mg/kg) for gastroenteritis-induced dehydration.
- Efficacy outcomes included vomiting episodes, oral fluid intake, weight gain, and need for IV rehydration or hospitalization.
- Diarrhea episodes were monitored for potential dose-related adverse effects.
Main Results:
- No significant association was found between ondansetron dose and vomiting episodes, fluid consumption, or weight gain.
- Higher ondansetron doses did not correlate with a reduced incidence of ongoing vomiting, hospitalization, or need for intravenous rehydration.
- The number of diarrhea episodes per hour also showed no dose-dependent relationship with ondansetron administration.
Conclusions:
- Within the 0.13-0.26 mg/kg range, higher oral ondansetron doses offer no superior efficacy for emesis control in pediatric gastroenteritis.
- Increased ondansetron dosage in this range was not linked to a higher occurrence of side effects, including diarrhea.
- Ondansetron effectively reduces emesis in children with acute gastroenteritis, with similar outcomes observed across the studied dose range.
Background:
Ondansetron is increasingly used to prevent emesis in children with acute gastroenteritis; however, the optimal dose is unknown.
Objective:
To determine if higher doses of oral ondansetron are associated with greater efficacy or side effects.
Methods:
We analyzed data from a prospective clinical trial performed between January 2004 and April 2005. Data were collected on 105 children with dehydration due to gastroenteritis who received an ondansetron oral disintegrating formulation. The following outcomes of efficacy were analyzed: number of vomiting episodes, volume of oral rehydration fluids consumed, percent weight gain, and the proportions of children who had ongoing vomiting, received intravenous rehydration, and were hospitalized. In addition, the number of episodes of diarrhea was evaluated to measure whether there were dose-dependent side effects.
Results:
Participants were aged 0.5-8.2 years and the dose ranged between 0.13 and 0.26 mg/kg. There was no significant association between the dose of ondansetron and the outcomes of number of vomiting episodes, volume of fluids consumed, increase in bodyweight, or number of diarrhea episodes/hour. The mean dose of ondansetron (mg/kg) administered was not different amongst those who did and did not have ongoing vomiting, undergo hospitalization, and receive intravenous rehydration.
Conclusions:
Within the dose range of 0.13-0.26 mg/kg, higher doses of ondansetron were not superior to lower doses, nor were they associated with increased side effects. Thus, ondansetron in this dose range was shown to result in a similar reduction in emesis in children with acute gastroenteritis.
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