Objectives: Determination of effect of oral dimenhydrinate in children with acute gastroenteritis, Design: This is a double-blind randomized clinical trial conducted on 200 children with gastroenteritis that patients referred to emergency ward of Mohammad Kermanshahi hospital. Setting and conduct: Patients were randomly assigned to two groups receiving dimenhydrinate and placebo groups. At 24 hours after the first administration of prescribed medication and after 7 to 14 days after discharge, the variables of interest are collected, Participants including major eligibility criteria: Diagnosis of acute gastroenteritis by Specialist Physicians, At least 5 episodes of vomiting in 12 Hours, Intervention: 4 doses of warfarin dose dimenhydrinate (1 mg / kg / dose to 50 mg / dose) or placebo for 4 doses during 6 days a week, main outcome variable: number of episodes of vomiting.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014083018974N1
Registration date:2015-03-02, 1393/12/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-03-02, 1393/12/11
Registrant information
Name
Simin Gheini
Name of organization / entity
Kermanshah University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3721 8202
Email address
s.gheini@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kermanshah University of Medical Sciences, Address: Vice chancellor for research, Building No. 2 of Kermanshah University of Medical Sciences, Shahidbeheshti Bolvar
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of effect of oral dimenhydrinate in children with acute gastroenteritis
Public title
Effects of dimenhydrinate in children with acute gastroenteritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Diagnosis of acute gastroenteritis by Specialist Physicians, At least 5 episodes of vomiting in 12 Hours; Aged between 1 to 12 years. Exclusion criteria: Chronic medical conditions of pre-existing such as gastrointestinal disease; malignancy; metabolic; cardiac; endocrine and metabolism, immune or nervous disorder. Secondary diagnosis of suspected from abdominal surgery or Or gynecologic conditions, urinary tract infections; migraine or meningitis. The use of antiemetic therapy in the 48 hours before the visit to the emergency. Use of other drugs such as acetaminophen or ibuprofen in the last 48 hours. History of allergies or adverse reactions to dimenhydrinate. Severe loss of water and requires urgent treatment with intravenous fluids. Hematemesis or hematochezia.
Age
From 1 year old to 12 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences Ethics Committee
Street address
Kermanshah University of Medical Sciences, Shahid Beheshti Bolvar, Kermanshah
City
Kermanshah
Postal code
Approval date
2013-12-17, 1392/09/26
Ethics committee reference number
40602
Health conditions studied
1
Description of health condition studied
acute gastroenteritis
ICD-10 code
K52.9
ICD-10 code description
Noninfective gastroenteritis and colitis, unspecified
Primary outcomes
1
Description
The number of vomiting episodes
Timepoint
Within 24 hours after using the first dose of prescription medication
Method of measurement
visit
Secondary outcomes
1
Description
The number of episodes of diarrhea
Timepoint
Within 24 hours after using the first dose of prescription medication
Method of measurement
visit
Intervention groups
1
Description
Dimenhydrinate 4 doses (1mg/kg dose max 200 mg/dose)
Category
Treatment - Drugs
2
Description
placebo doses (1 mg / kg / dose to 50 mg / dose) during 6 days per week
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Mohammad Kermanshahi Hospital
Full name of responsible person
Ameli Somayeh
Street address
Mohammad Kermanshahi Hospital, HelalAhmar, Kermanshah
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Vice chancellor for research, Building No. 2 of Kermanshah University of Medical Sciences, Shahidbeheshti Bolvar
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah university of medical sciences
Full name of responsible person
Reza Akramipour
Position
Chief of Department of Pediatrics
Other areas of specialty/work
Street address
Mohammad Kemanshahi Hospital, Helal Ahmar Ave
City
Kermanshah
Postal code
Phone
+98 83 3721 8202
Fax
Email
Akramipur20@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah university of medical sciences
Full name of responsible person
Simin Gheini
Position
Phd
Other areas of specialty/work
Street address
Mohammad Kemanshahi Hospital, Helal Ahmar Ave
City
Kermanshah
Postal code
Phone
+98 83 3721 8202
Fax
Email
SiminGheini@yahoo.com,
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah university of medical sciences
Full name of responsible person
dr somayeh Ameli
Position
Rezident of Pediatric
Other areas of specialty/work
Street address
Mohammad Kemanshahi Hospital, Helal Ahmar Ave
City
Kermanshah
Postal code
Phone
+98 83 3721 8202
Fax
Email
drsameli@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)