drugset / Trial / NCT01870635

Ondansetron Administration to WELL Children With Gastroenteritis Associated Vomiting in EDs in Pakistan

NCT01870635 ↗

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective is to determine if the administration of a single dose of oral ondansetron (an anti-vomiting medication), compared to placebo, results in a reduction in intravenous (IV) rehydration therapy in children presenting for emergency department care with vomiting and diarrhea in Pakistan.

Timeline

Start
2014-05
Primary completion
2017-01-20
Completion
2017-02-03

Outcome

Missed primary endpoint

paper CONCLUSION: Oral administration of a single dose of ondansetron did not result in a reduction in intravenous rehydration use. PMID 30392735 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Ondansetron Other / unclassified 2 mg Oral
Subject Ondansetron Other / unclassified 4 mg Oral