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A Trial Comparing the Effect of Oral Dimenhydrinate Versus Placebo in Children With Gastroenteritis (GAG)

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ClinicalTrials.gov Identifier: NCT00124787
Recruitment Status : Completed
First Posted : July 28, 2005
Last Update Posted : March 1, 2012
Sponsor:
Collaborator:
Canadian Association of Emergency Physicians
Information provided by (Responsible Party):
Serge Gouin, St. Justine's Hospital

Study Description
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Brief Summary:

Dimenhydrinate, an over-the-counter, widely used drug in Canada, is an ethanolamine-derivative anti-histamine. It limits the stimulation of the vomiting center by the vestibular system, which is rich in histamine receptors. Multiple studies have shown its effectiveness in treatment of post-operative nausea and vomiting in children. It is also used for treatment of vertigo in children. Furthermore, it has the potential to be much more cost-effective than ondansetron, with an average cost of $0.90 US per dose . Its principal side effects are drowsiness, dizziness and anticholinergic symptoms. Restlessness and insomnia have also been described in children. To date, there has been no published data on the efficacy of dimenhydrinate in controlling emesis in children with acute gastroenteritis.

RESEARCH QUESTION

Do children treated with oral dimenhydrinate during acute gastro-enteritis experience less vomiting episodes than children treated with placebo?


Condition or disease Intervention/treatment Phase
Gastroenteritis Drug: Dimenhydrinate Drug: Placebo Phase 4

Detailed Description:

STRUCTURED RESEARCH ABSTRACT

Background: The use of antiemetic drugs to treat nausea and vomiting during an episode of acute gastroenteritis in children remains controversial. To date, there have been a limited number of clinical trials studying this subject matter and health authorities' recommendations are only based on expert opinion. Surveys have shown that despite this lack of evidence, physicians do quite frequently prescribe these drugs. Dimenhydrinate, a histamine receptor blocker, has been proven safe and effective in controlling post-operative nausea and vomiting in children. To our knowledge, no clinical trial has been conducted to study its efficacy in children with acute gastroenteritis.

Objective: To evaluate the efficacy and safety of oral dimenhydrinate in the treatment of vomiting due to acute gastroenteritis in children.

Design: Randomized, double-blind, placebo controlled clinical trial.

Setting: Emergency Department (ED) of an urban pediatric university-affiliated center.

Study population: Children from 1 to 12 years of age presenting to the ED with at least 5 episodes of vomiting in the previous 12 hours and diagnosed with acute gastroenteritis by attending physicians.

Interventions: Study participants will be randomly allocated to receive 8 doses of dimenhydrinate or placebo every six hours (1mg/kg/dose, max dose 50mg/dose)

Primary outcome measure: Number of good outcome, defined as 1 episode or less of vomiting 24 hours after the first dose of drug administration.

Secondary outcome measures: Need for intravenous fluid administration, number and duration of vomiting and diarrhea, side effects, revisit rates and parental absenteeism from work will be compared between the two groups

Sample size and statistics: Based on previously reported data, the researchers estimate that approximately 70% of patients will be free of emesis in the initial 24 hours post medication first dose. The researchers would like to obtain a good outcome in more than 85% with the active medication. With an alpha error of 0.05 and a power of 90%, approximately 90 patients per group will be needed. Patients' characteristics and outcomes will be compared using the Mann Whitney U test and the Chi-square test for categorical variables and the Student's T test for continuous variables. Survival curves will also be analyzed.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Double-blind Trial Comparing the Effect of Oral Dimenhydrinate Versus Placebo in Children With Moderate Vomiting Due to Acute Gastroenteritis
Study Start Date : April 2005
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Dimenhydrinate
dimenhydrinate PO x 4 doses
 Drug: Dimenhydrinate
Dimenhydrinate PO q 6 hours x 4 doses
Placebo Comparator: Placebo
placebo PO x 4 doses
 Drug: Placebo
Placebo PO q 6 hours x 4 doses


Outcome Measures
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Primary Outcome Measures :
  1. Number of good outcome, defined as 1 episode or less of vomiting 24 hours after the first dose of drug administration. [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Need for intravenous fluid administration [ Time Frame: 24 hours ]
  2. Number and duration of vomiting and diarrhea [ Time Frame: 7 days ]
  3. Side effects [ Time Frame: 7 days ]
  4. Revisit rates [ Time Frame: 7 days ]
  5. Parental absenteeism from work will be compared between the two groups [ Time Frame: 7 days ]

Eligibility Criteria
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Ages Eligible for Study:   1 Year to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children aged from 1 to 12 years old with more than 5 episodes of vomiting in the 12 hours preceding their diagnosis of acute gastroenteritis by an ED attending physician

Exclusion Criteria:

  • Pre-existing chronic medical condition such as gastro-intestinal disease, malignancy, metabolic, cardiac, endocrine, immunologic or neurologic disorder
  • Suspected secondary diagnosis of surgical abdomen or gynecologic condition, urinary tract infection, migraine or meningitis
  • Use of antiemetic therapy within 48 hours prior to ED visit
  • Use of medication other than acetaminophen or ibuprofen in the previous 48 hours
  • History of allergy or adverse reaction to dimenhydrinate
  • Severe dehydration requiring immediate intravenous fluid therapy
  • Hematemesis or hematochezia
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00124787


Locations
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Canada, Quebec
Ste-Justine Hospital
Montreal, Quebec, Canada, H3T 1C5
Sponsors and Collaborators
St. Justine's Hospital
Canadian Association of Emergency Physicians
Investigators
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Principal Investigator: Serge Gouin, MDCM, FRCPC Ste-Justine Hospital, Department of Pediatrics, Montreal University
More Information
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Responsible Party: Serge Gouin, Associate professor, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT00124787    
Other Study ID Numbers: PROJET 2078
First Posted: July 28, 2005    Key Record Dates
Last Update Posted: March 1, 2012
Last Verified: February 2012
Additional relevant MeSH terms:
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Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Dimenhydrinate
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action