Ondansetron Administration to Children With Gastroenteritis, Vomiting and SOME Dehydration in EDs in Pakistan

Phase 4 Completed 918 enrolled Dr. Stephen Freedman Aga Khan University · collab Bill and Melinda Gates Foundation · collab Thrasher Research Fund · collab

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 some dehydration, vomiting and diarrhea in Pakistan. SOME Dehydration is defined as 2 or more of the following signs and symptoms: * Restlessness, irritability * Sunken Eyes * Drinks eagerly, thirsty * Skin pinch goes back slowly

Timeline

Start: 2014-05
Primary completion: 2017-12
Completion: 2017-12

Outcome

Missed primary endpoint

paper children administered ondansetron had lower odds of the primary outcome (odds ratio: 0.70; 95% CI, 0.49 to 1.00). PMID 31694979 ↗

Publications

Freedman SB, Soofi SB, Willan AR, Williamson-Urquhart S, Siddiqui E, Xie J, Dawoud F, Bhutta ZA. Oral Ondansetron Administration to Dehydrated Children in Pakistan: A Randomized Clinical Trial. Pediatrics. 2019 Dec;144(6):e20192161. doi: 10.1542/peds.2019-2161. Epub 2019 Nov 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ondansetron	Other / unclassified	2 mg	Oral
Subject	Ondansetron	Other / unclassified	4 mg	Oral