A Trial Comparing the Effect of Oral Dimenhydrinate Versus Placebo in Children With Gastroenteritis - Full Text View

Sponsor:	St. Justine's Hospital
Collaborator:	Canadian Association of Emergency Physicians
Information provided by (Responsible Party):	Serge Gouin, St. Justine's Hospital
ClinicalTrials.gov Identifier:	NCT00124787

Purpose

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	Intervention	Phase
Gastroenteritis	Drug: Dimenhydrinate Drug: Placebo	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Dizziness and Vertigo Gastroenteritis Nausea and Vomiting

Drug Information available for: Dimenhydrinate

U.S. FDA Resources

Further study details as provided by St. Justine's Hospital:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Need for intravenous fluid administration [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Number and duration of vomiting and diarrhea [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Side effects [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
Revisit rates [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Parental absenteeism from work will be compared between the two groups [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Enrollment:	150
Study Start Date:	April 2005
Study Completion Date:	February 2012
Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	1 Year to 12 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00124787

Locations

Canada, Quebec
Ste-Justine Hospital
Montreal, Quebec, Canada, H3T 1C5

Sponsors and Collaborators

St. Justine's Hospital

Canadian Association of Emergency Physicians

Investigators

Principal Investigator:

Serge Gouin, MDCM, FRCPC

Ste-Justine Hospital, Department of Pediatrics, Montreal University

More Information

No publications provided

Responsible Party:	Serge Gouin, Associate professor, St. Justine's Hospital
ClinicalTrials.gov Identifier:	NCT00124787 History of Changes
Other Study ID Numbers:	PROJET 2078
Study First Received:	July 26, 2005
Last Updated:	February 29, 2012
Health Authority:	Canada: Health Canada

Additional relevant MeSH terms:

Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Dimenhydrinate
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2012