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

April 16, 2018 updated by: Stephen Freedman, The Hospital for Sick Children

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Outcome Measures

Outcome Measure
To compare in each treatment arm: mean number of episodes of vomiting, the proportion of children administered supplemental intravenous rehydration or requiring hospitalization.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Collaborators

GlaxoSmithKline
Ann & Robert H Lurie Children's Hospital of Chicago
National Center for Research Resources (NCRR)

Investigators

  • Principal Investigator: Stephen B Freedman, MDCM, MSCI, The Hospital for Sick Children

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

April 1, 2005

Study Completion (Actual)

April 1, 2005

Study Registration Dates

First Submitted

July 12, 2005

First Submitted That Met QC Criteria

July 18, 2005

First Posted (Estimate)

July 19, 2005

Study Record Updates

Last Update Posted (Actual)

April 17, 2018

Last Update Submitted That Met QC Criteria

April 16, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2003-12038

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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