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A pragmatic randomized controlled trial of multi-dose oral ondansetron for pediatric gastroenteritis (the DOSE-AGE
Anna Heath1,2,3, Juan David Rios4, Sarah Williamson-Urquhart5
1University of Toronto, Toronto, Ontario, Canada. anna.heath@sickkids.ca.
Insights
This study investigates if multiple doses of ondansetron reduce symptoms in children with gastroenteritis. The trial aims to determine the effectiveness and safety of additional ondansetron doses beyond the emergency department.
Area of Science:
- Pediatric Emergency Medicine
- Clinical Pharmacology
- Gastroenterology
Background:
- Acute gastroenteritis is a common cause of pediatric emergency department visits and hospitalizations.
- Oral rehydration is recommended, but vomiting often leads to intravenous rehydration.
- Ondansetron administered in the ED reduces vomiting, but evidence for additional doses is limited.
Purpose of the Study:
- To evaluate the effectiveness of multiple oral doses of ondansetron for treating acute gastroenteritis-associated vomiting in children.
- To assess the safety of repeat ondansetron dosing, including diarrheal episodes and adverse events.
- To provide evidence-based guidelines for ondansetron use in pediatric gastroenteritis.
Main Methods:
- Phase III, multi-center, placebo-controlled, double-blind, randomized controlled trial (DOSE-AGE study).
- Participants receive either multiple doses of oral ondansetron or placebo as needed after ED discharge.
- Outcomes measured include the Modified Vesikari Scale score, diarrheal episodes, and caregiver satisfaction.
Main Results:
- This article outlines the statistical analysis plan (SAP) for the DOSE-AGE trial.
- The SAP details the methodology for analyzing primary and secondary outcomes.
- The study aims to minimize data-driven results and bias through pre-specified analysis.
Conclusions:
- The DOSE-AGE trial will determine the effectiveness of multi-dose oral ondansetron for pediatric gastroenteritis-associated vomiting.
- The findings will inform clinical practice regarding the use of ondansetron post-emergency department visit.
- This SAP ensures rigorous and unbiased analysis of the trial data.
Background:
Acute gastroenteritis is a leading cause of emergency department visits and hospitalizations among children in North America. Oral-rehydration therapy is recommended for children with mild-to-moderate dehydration, but children who present with vomiting are frequently offered intravenous rehydration in the emergency department (ED). Recent studies have demonstrated that the anti-emetic ondansetron can reduce vomiting, intravenous rehydration, and hospitalization when administered in the ED to children with dehydration. However, there is little evidence of additional benefit from prescribing ondansetron beyond the initial ED dose. Moreover, repeat dosing may increase the frequency of diarrhea. Despite the lack of evidence and potential adverse side effects, many physicians across North America provide multiple doses of ondansetron to be taken following ED disposition. Thus, the Multi-Dose Oral Ondansetron for Pediatric Gastroenteritis (DOSE-AGE) trial will evaluate the effectiveness of prescribing multiple doses of ondansetron to treat acute gastroenteritis-associated vomiting. This article specifies the statistical analysis plan (SAP) for the DOSE-AGE trial and was submitted before the outcomes of the study were available for analysis.
Methods/Design:
The DOSE-AGE study is a phase III, 6-center, placebo-controlled, double-blind, parallel design randomized controlled trial designed to determine whether participants who are prescribed multiple doses of oral ondansetron to administer, as needed, following their ED visit have a lower incidence of experiencing moderate-to-severe gastroenteritis, as measured by the Modified Vesikari Scale score, compared with a placebo. To assess safety, the DOSE-AGE trial will investigate the frequency and maximum number of diarrheal episodes following ED disposition, and the occurrence of palpitations, pre-syncope/syncope, chest pain, arrhythmias, and serious adverse events. For the secondary outcomes, the DOSE-AGE trial will investigate the individual elements of the Modified Vesikari Scale score and caregiver satisfaction with the therapy.
Discussion:
The DOSE-AGE trial will provide evidence on the effectiveness of multiple doses of oral ondansetron, taken as needed, following an initial ED dose in children with acute gastroenteritis-associated vomiting. The data from the DOSE-AGE trial will be analyzed using this SAP. This will reduce the risk of producing data-driven results and bias in our reported outcomes. The DOSE-AGE study was registered on ClinicalTrials.gov on February 22, 2019.
Trial Registration:
ClinicalTrials.gov NCT03851835 . Registered on 22 February 2019.
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