NCT00120744

Oral Disintegrating Ondansetron Tablet to Reduce Vomiting From Gastroenteritis in a Pediatric Emergency Department

Randomized Trial of the Oral Disintegrating Ondansetron Tablet to Reduce Vomiting From Acute Gastroenteritis in a Pediatric Emergency Department

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: —
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 6 Months – 10 Years
• Healthy volunteers: Not accepted

Summary

The objectives of the study were to determine whether ondansetron treatment would reduce: * the amount of vomiting in the emergency department; * the need for intravenous rehydration; and * the need for hospitalization.

Detailed description

Background: Vomiting may limit the success of oral rehydration in children with gastroenteritis and dehydration. Limited data suggest that while oral ondansetron may reduce vomiting from gastroenteritis, emergency department revisits may increase. Methods: The investigators conducted a prospective, double-blind randomized trial at a pediatric emergency department in 214 dehydrated children, aged 6 months to 10 years with gastroenteritis and mild to moderate dehydration as assessed by a dehydration score. They were randomly assigned to receive treatment with an ondansetron oral disintegrating tablet or placebo. Oral rehydration was administered according to a standard protocol. The primary outcome was the proportion of children who vomited during oral rehydration therapy. The secondary outcomes were the mean number of episodes of vomiting, and the proportion of children treated with intravenous rehydration or hospitalized.

Conditions

• Gastroenteritis
• Vomiting
• Diarrhea
• Dehydration

Interventions

Type	Name	Description
DRUG	Ondansetron Oral Disintegrating Tablet

Timeline

• Start date: 2004-01-01
• Primary completion: 2005-04-01
• Completion: 2005-04-01
• First posted: 2005-07-19
• Last updated: 2018-04-17