The goal of this trial is to compare the effect of oral ondansetron with placebo, in treatment of vomiting due to acute gastroenteritis in infants and children (treatment with oral rehydration therapy and based on WHO protocol). A total of 176 patients with simple acute gastroenteritis, aged between 1 and 10 years, will be included. In a double blind fashion, the patients will be randomized to receive oral ondansetron or placebo tablets (Dosage of drug will be set based on weight of children). 30 minutes after administration, ORS will be prescribed (based on age and weigh of patient and based on WHO protocol). If no vomiting occurs during 4 hours of ORT, treatment has been successful, but if vomiting continues, treatment is not successful and patient will go on treatment based on hospital protocol. After 4 hours, the patient will be evaluated again and discharged based on WHO guidelines. After 48 hours, incidence of possible vomiting will be asked by telephone.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138710221545N1
Registration date:2011-02-26, 1389/12/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-02-26, 1389/12/07
Registrant information
Name
Hamidreza Badeli
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1322 9523
Email address
badeli@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research, Guilan University of Medical Sciences
Expected recruitment start date
2010-12-22, 1389/10/01
Expected recruitment end date
2011-03-21, 1390/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of oral Ondansetron on Decreasing the Vomiting Associated With Acute Gastroenteritis in pediatrics
Public title
Effect of oral Ondansetron on Decreasing the Vomiting Associated With Acute Gastroenteritis in pediatrics
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 1 to 10 years old, Simple acute gastroenteritis, mild to moderate dehydration, Onset of disease in 24 hours prior to the study, At least one episode of vomiting in 6 hours ago, no fever or low grade fever
Exclusion criteria: infants and children that use any antivomiting drugs, Any chronic disease, Alarm signs such as headache or abdominal distension, Severe dehydration or shock, Sever diarrhea more than one episode in an hour, Any previous unfavorable response to 5HT3 receptor inhibitor drugs, Any situation that ORT is not recommended
Age
From 1 year old to 10 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
176
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
Vice Chancellor for research, Guilan University of Medical Sciences
Street address
Vice Chancellor for research, Guilan University of Medical Sciences, Mellat Street, Namjoo Avenue
City
Rasht
Postal code
Approval date
2010-09-28, 1389/07/06
Ethics committee reference number
10229
Health conditions studied
1
Description of health condition studied
Acute gastroenteritis
ICD-10 code
A09
ICD-10 code description
Diarrhoea and gastroenteritis of presumed infectious origin
Primary outcomes
1
Description
Vomiting
Timepoint
4 hours and 48 hours after oral ondansetron administration
Method of measurement
Direct inspection and asking patient`s parents
Secondary outcomes
1
Description
Bradycardia
Timepoint
4 hors after oral ondansetron administration
Method of measurement
Physical examination
2
Description
Skin rash
Timepoint
4 hors after oral ondansetron administration
Method of measurement
Physical examination
3
Description
Tachycardia
Timepoint
4 hors after oral ondansetron administration
Method of measurement
Physical examination
4
Description
Headache
Timepoint
4 hors after oral ondansetron administration
Method of measurement
History
5
Description
diarrhea
Timepoint
4 hours after oral ondansetron administration
Method of measurement
History
Intervention groups
1
Description
Ondansetron tablets, 30 minutes before ORT, with dosage adjusting based on patient`s weight
( Using ondansetron 4 mg tablets )
Category
Treatment - Drugs
2
Description
Placebo tablets, 30 minutes before ORT
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
17 Shahrivar Hospital of Rasht
Full name of responsible person
Street address
17 Shahrivar Hospital- Namjoo st
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research, Guilan University of Medical Sciences
Full name of responsible person
Dr. Abdolrasol Sobhani
Street address
Vice Chancellor for research, Guilan University of Medical Sciences, Mellat Street, Namjoo Avenue
City
Rasht
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, Guilan 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
17 shahrivar hospital
Full name of responsible person
Hamidreza Badeli
Position
Pediatric Nephrologist,Assistant Professor
Other areas of specialty/work
Street address
17 shahrivar Hospital. Namjoo street
City
Rasht
Postal code
Phone
+98 13 1322 9523
Fax
Email
badeli@gums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
17 shahrivar hospital
Full name of responsible person
Hamidreza badeli
Position
Pediatric Nephrologist,Assistant Professor
Other areas of specialty/work
Street address
17 shahrivar Hospital. Namjoo street
City
Rasht
Postal code
Phone
+98 13 1322 9523
Fax
Email
badeli@gums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Saman Rezaeian
Position
Medical Student
Other areas of specialty/work
Street address
Student
City
Rasht
Postal code
4138673557
Phone
Fax
Email
Saman8484@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)