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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00120744
First Posted: July 19, 2005
Last Update Posted: December 11, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Center for Research Resources (NCRR)
GlaxoSmithKline
Ann & Robert H Lurie Children's Hospital of Chicago
Information provided by (Responsible Party):
Stephen Freedman, The Hospital for Sick Children
July 12, 2005
July 19, 2005
December 11, 2013
January 2004
April 2005   (Final data collection date for primary 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.
Same as current
Complete list of historical versions of study NCT00120744 on ClinicalTrials.gov Archive Site
To compare in each treatment arm: mean number of episodes of vomiting, the proportion of children administered supplemental intravenous rehydration or requiring hospitalization.
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
  • Gastroenteritis
  • Vomiting
  • Diarrhea
  • Dehydration
Drug: Ondansetron Oral Disintegrating Tablet
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
April 2005
April 2005   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
6 Months to 10 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00120744
2003-12038
Not Provided
Not Provided
Not Provided
Stephen Freedman, The Hospital for Sick Children
The Hospital for Sick Children
  • National Center for Research Resources (NCRR)
  • GlaxoSmithKline
  • Ann & Robert H Lurie Children's Hospital of Chicago
Principal Investigator: Stephen B Freedman, MDCM, MSCI The Hospital for Sick Children
The Hospital for Sick Children
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP