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

This study has been completed.
Sponsor:
Collaborators:
GlaxoSmithKline
Ann & Robert H Lurie Children's Hospital of Chicago
Information provided by (Responsible Party):
Stephen Freedman, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00120744
First received: July 12, 2005
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

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.

Condition Intervention
Gastroenteritis
Vomiting
Diarrhea
Dehydration
Drug: Ondansetron Oral Disintegrating Tablet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Randomized Trial of the Oral Disintegrating Ondansetron Tablet to Reduce Vomiting From Acute Gastroenteritis in a Pediatric Emergency Department

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

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

Study Start Date: January 2004
Study Completion Date: April 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   6 Months to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00120744

Sponsors and Collaborators
The Hospital for Sick Children
GlaxoSmithKline
Ann & Robert H Lurie Children's Hospital of Chicago
Investigators
Principal Investigator: Stephen B Freedman, MDCM, MSCI The Hospital for Sick Children
  More Information

Additional Information:
No publications provided

Responsible Party: Stephen Freedman, Adjunct Scientist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00120744     History of Changes
Other Study ID Numbers: 2003-12038
Study First Received: July 12, 2005
Last Updated: December 10, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dehydration
Diarrhea
Emergencies
Gastroenteritis
Vomiting
Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Disease Attributes
Gastrointestinal Diseases
Digestive System Diseases
Ondansetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents

ClinicalTrials.gov processed this record on July 22, 2014