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Ondansetron Administration to WELL Children With Gastroenteritis Associated Vomiting in Emergency Departments in Pakistan (OWEP)
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.
Details
| Lead sponsor | Dr. Stephen Freedman |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 625 |
| Start date | 2014-05 |
| Completion | 2017-02-03 |
Conditions
- Dehydration
- Gastroenteritis
- Vomiting
- Diarrhea
Interventions
- Ondansetron
- Placebo
Primary outcomes
- Intravenous (IV) Rehydration — within 72 hours of randomization
IV rehydration is defined as the IV administration of ≥20 ml/kg over 4 hours of an isotonic fluid for the purpose of rehydration within 72 hours of randomization. This definition allows for the occurrence of the primary outcome in children who receive maintenance plus replacement of losses and not simply those who receive a fluid bolus. This will not include those who simply receive maintenance fluids (e.g. 4 ml/kg/hr for those weighing \< 10 kg). This will also enable us to exclude children who undergo IV insertion for the purpose of medication administration. IV rehydration is a powerful marker of treatment failure, a decrease in which is likely to impact practice and influence decision makers since it is drastically more expensive that ORT, it is painful and is associated with a greater risk of adverse events.
Countries
Pakistan