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OpenTrials
Completed

NCT Number: NCT00120744

Oral Disintegrating Ondansetron Tablet to Reduce Vomiting From 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.

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Key information

Conditions

Gastroenteritis Dehydration Diarrhea Digestive System Diseases Gastrointestinal Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting Water-Electrolyte Imbalance

Age range

6 month–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ondansetron Oral Disintegrating Tablet

Drug

Primary outcomes

  1. 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 outcomes

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

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Jul 19, 2005
Registry last updated
Apr 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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