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

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

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

Indications