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

Diarrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00120744
• Other study ID #: 2003-12038
• Status: Completed
• Phase: N/A
• First received: July 12, 2005
• Last updated: April 16, 2018
• Start date: January 2004
• Est. completion date: April 2005

Study information

• Verified date: April 2018
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: April 2005
• Est. primary completion date: April 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 10 Years

Eligibility

Inclusion Criteria:

• Acute gastroenteritis

• Non-bilious and non-bloody vomiting within 4 hours of triage

• Diarrhea

• Mild to moderate dehydration

Exclusion Criteria:

• Weight less than 8 kilograms

• Severe dehydration

• Underlying disease which might affect the assessment of hydration status (e.g., chronic renal failure, hypoalbuminemia, congestive heart failure, on diuretics)

• History of abdominal surgery

• Hypersensitivity to the drug or any components in its formulation

Related Conditions & MeSH terms

• Dehydration
• Diarrhea
• Emergencies
• Gastroenteritis
• Vomiting

Intervention

Drug:
• Ondansetron Oral Disintegrating Tablet

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Ann & Robert H Lurie Children's Hospital of Chicago, GlaxoSmithKline, National Center for Research Resources (NCRR)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of children who vomit during oral rehydration therapy after receiving either 0.13-0.27 mg per kilogram of an oral disintegrating ondansetron tablet or placebo.
Secondary	To compare in each treatment arm: mean number of episodes of vomiting, the proportion of children administered supplemental intravenous rehydration or requiring hospitalization.

External Links

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