Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00124787
Status:
COMPLETED
Last Update Posted:
2012-03-01
First Post:
2005-07-26
Brief Title:
A Trial Comparing the Effect of Oral Dimenhydrinate Versus Placebo in Children With Gastroenteritis
Sponsor:
St Justines Hospital
Organization:
St Justines Hospital
Study Overview
Official Title:
A Randomized Double-blind Trial Comparing the Effect of Oral Dimenhydrinate Versus Placebo in Children With Moderate Vomiting Due to Acute Gastroenteritis
Status:
COMPLETED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GAG
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 090 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
RESEARCH QUESTION
Do children treated with oral dimenhydrinate during acute gastro-enteritis experience less vomiting episodes than children treated with placebo
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 1mgkgdose max dose 50mgdose
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 005 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 Students T test for continuous variables Survival curves will also be analyzed
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 1mgkgdose max dose 50mgdose
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 005 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 Students T test for continuous variables Survival curves will also be analyzed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None