To assess the effect of injective ondansetron on decreasing hospitalization rate in children with Gastroenteritis and recurrent vomiting
Design: This study is Randomized- controlled clinical trial in 200 patients with Gastroenteritis (GE) referred to Qods hospital, during 2014-2015. Patients recruiting in this study, randomly assigned in two groups based on Balanced Block Randomization. We have 6 Blocks (AABB-BBAA-ABAB-BABA-BAAB-ABBA) that based on random will be arranged. Control group receive routine plan ( Metoclopramid ) and intervention group receive Ondansetron. They are followed through hospital reception documents and telephone call until 72 hours after discharge. This follow up is to find out whether the patients have had any need to be returned to hospital because of recurrence of vomiting or not.
Inclusion criteria: Acute GE with recurrent vomiting
Exclusion criteria: Other causes (bacterial GE, protozoan GE, etc.) or vomiting secondary to other diseases.
Sample size: Two hundred patients.
Intervention: patients between six months and six years old, because of acute GE are assessed for their response to injection of a single dose of 0.15 mg/Kg Ondansetron and possibility of treat them as out-patients cases. Meanwhile, other cases in similar situation are selected as control group who receive 1 mg/ kg Metoclopramid. All cases are treated with serum.. All individuals are under observe for at least two hours and after making sure about disrupt of vomiting following oral feeding, are discharged from emergency ward of hospital.
Intervention time: Two weeks
Primary outcome: The rate and duration of hospitalization are analyzed statistically.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014090719077N1
Registration date:2014-11-22, 1393/09/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-11-22, 1393/09/01
Registrant information
Name
Sonia Oveisi
Name of organization / entity
Qazvin Unversity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6001
Email address
soveisi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Qazvin University of Medical Sciences
Expected recruitment start date
2014-10-16, 1393/07/24
Expected recruitment end date
2014-11-14, 1393/08/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Ondansetron on decreasing hospitalization rate in children with gustroenteritis and recurrent vomiting
Public title
The effect of Ondansetron in children suffered from Gastroenteritis and recurrent vomiting
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with the evidence of viral GE that recurrent vomiting are the only indication of referring them to hospital and the time of their referral to the hospital is not more than 48 hours after the beginning of the symptoms exclusion criteria: Other cases with other causes (bacterial GE, protozoan GE, etc.) or vomiting secondary to other diseases and patients with symptoms prolonger than 48 hours
Age
From 6 months old to 6 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Shahid Bahonar blvd, Vice chancellor for research, Qazvin University of Medical Sciences, Qazvin
City
Qazvin
Postal code
Approval date
2014-02-20, 1392/12/01
Ethics committee reference number
8740
Health conditions studied
1
Description of health condition studied
Gastroenteritis
ICD-10 code
k52
ICD-10 code description
Gastroenteritis
Primary outcomes
1
Description
whether the patients have any need to be returned to hospital because of recurrence of vomiting or not
Timepoint
1 week
Method of measurement
percent of patients with hospitalization
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Intervention group: Injection of Ondansetron , 0.15 mg per kg . Single dose with serum normal saline will be injected.AMP DEMITRON ( Ondansetron) 4MG/2ML that vials are manufactured by Tehran- Chemistry company
Category
Treatment - Drugs
2
Description
Control group: Injection of1 mg per KG of Metoclopramide single dose with serum Normal Saline. METOCLOPRAMIDE DAROUPAKHSH 10MG/2ML AMP
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Qods Hospital
Full name of responsible person
Maryam Darabi
Street address
Qods Hospital, Qods St., Qazvin
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Qazvin University of Medical Sciences
Full name of responsible person
Dr. Naserpoor
Street address
Vice chancellor for research, Shahid Bahonar blvd., Qazvin University of Medical Sciences, Qazvin
City
Qazvin
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, Qazvin 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Metabolic Diseases Research Center, Qazvin University of Medical Sciences
Full name of responsible person
Dr. Sonia Oveisi
Position
Assistant Professor
Other areas of specialty/work
Street address
Qazvin Metabolic Diseases Research Center, Booali-Sina Hospital, Booali-Sina St. , Qazvin
City
Qazvin
Postal code
Phone
+98 28 3336 0084
Fax
Email
soveisi@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)