Investigating the effectiveness of a single dose of ondansetron in reducing the need for hospitalization or intravenous fluid therapy in children with gastroenteritis
Determining the effectiveness of a single dose of ondansetron in reducing the need for hospitalization or IV fluid therapy in children with gastroenteritis
Design
The clinical trial has a control group with parallel groups, double-blind, randomized and on a total of 60 patients. In this study, simple randomization was used by creating a random sequence in Excel and hiding it for the researcher.
Settings and conduct
After randomization, children with gastroenteritis who refer to the emergency room of Imam Hossein Children's Hospital and meet the inclusion and exclusion criteria are assigned to one of the two drug intervention or control groups. The control group will be given a placebo and the intervention group will be given medication to control vomiting and start oral fluid therapy. The doctor and the patients are not aware that they have received the drug or the placebo. Up to 4 hours after the start of oral fluid therapy, the patient will be monitored for the main outcomes.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children 6 months to 6 years with acute non-bloody diarrhea with mild to moderate dehydration and vomiting in the last 4 hours
Exclusion criteria: Severe shock and dehydration and the presence of surgical reasons for vomiting
Intervention groups
Patients are placed in two groups of 30 people randomly. The control group receives placebo and the intervention group receives ondansetron. Both groups receive other standard treatments for diarrhea, including oral fluid therapy and zinc syrup, and advice on warning signs.
Main outcome variables
repeated vomiting; tolerance of oral fluid therapy; need for hospitalization; The need for intravenous fluid therapy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220128053852N1
Registration date:2023-03-04, 1401/12/13
Registration timing:prospective
Last update:2023-03-04, 1401/12/13
Update count:0
Registration date
2023-03-04, 1401/12/13
Registrant information
Name
Minoo Saeidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3386 6266
Email address
minoo.saeidi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-21, 1402/01/01
Expected recruitment end date
2023-06-20, 1402/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of a single dose of ondansetron in reducing the need for hospitalization or intravenous fluid therapy in children with gastroenteritis
Public title
Ondansetrin in pediatruc Gastroentritis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 6 and 60 months
At least once watery and loose diarrhea in 24 hours
Vomiting at least once in the last 4 hours
Patients with mild to moderate dehydration
Exclusion criteria:
Severe dehydration or hypovolemic shock
Surgical causes of vomiting
Adverse drug reaction to Ondansetron
Bloody vomiting
Severe abdominal distention or ileous
Congenital or aquired cardiac diseases
Under 6 months infants
Bloody stool
Age
From 6 months old to 60 months old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
we will use blocked randomisation. Using the Random Allocation software 2.0, for 2 study groups, 10 blocks of 6 were calculated for a sample size of 60 people, and each person will be identified with a unique code (consisting of two letters and a Latin number). To assign the child to each of the 2 study groups, an envelope containing a unique code and treatment group will be delivered to the child's parents. The associate nurse of the plan, who is stationed next to the nurse in charge of fluid therapy, will open the envelope and determine the type of intervention before the patient's admission.
Blinding (investigator's opinion)
Double blinded
Blinding description
We put ondansetron and placebo in identical packages and write code A or B on the package. As much as possible, the appearance of the medicine is not visible to the parents. Only the researcher is aware of which A and B are the intervention group and which is the control group, and the rest of the people involved, including the doctor and the person in charge of data analysis, are not aware.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Isfahan University of Medical Sciences
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8174602647
Approval date
2022-10-06, 1401/07/14
Ethics committee reference number
IR.MUI.MED.REC.1401.252
Health conditions studied
1
Description of health condition studied
Acute gastroentritis in children
ICD-10 code
A08.4
ICD-10 code description
Viral intestinal infection, unspecified
Primary outcomes
1
Description
The need for intravenous fluid therapy
Timepoint
During the first 4 hours of receiving the drug and placebo, the patient's symptoms are evaluated every hour
Method of measurement
Clinical judgment of the doctor and the degree of dehydration of the patient
Secondary outcomes
1
Description
Repeated vomiting
Timepoint
First 4 hours after intervention
Method of measurement
History taking
Intervention groups
1
Description
Control group: 5 cc of placebo that is as similar in appearance, color, and taste as possible to the original drug. The placebo drug will be prepared by the pharmacy of Dr. Sabzeqabaei, a member of the Faculty of Pharmacy Department of Isfahan Pareshki University of Sciences, and it will be prepared as a solution with the color, smell, and consistency as similar as possible to the original drug.
Category
Placebo
2
Description
Intervention group: Fifteen hundred milligrams per kilogram of the patient's weight of Andasterone is taken orally for one dose. Ondansetron Syrup is a product of Exir Pharmaceutical Company and contains 4 mg of drug per 5 cc of solution.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Children's Hospital
Full name of responsible person
Minoo Saeidi
Street address
Imam Khomeini
City
Isfehan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 6266
Fax
+98 31 3386 8286
Email
emamhossein_hospital@mui.ac.ir
Web page address
http://www.ehuch.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Minoo Saeidi
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
minoo.saeidi@gmail.com
Web page address
https://mui.ac.ir/en
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Minoo Saeidi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Isfahan university of medical sciences
City
Isfahan
Province
Isfehan
Postal code
8174602647
Phone
+98 31 3668 0048
Email
minoo.saeidi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Minoo Saeidi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8174602647
Phone
+98 31 3668 0048
Email
minoo.saeidi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Minoo Saeidi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8174602647
Phone
+98 31 3668 0048
Email
minoo.saeidi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data after de-identification
When the data will become available and for how long
6 months after the results are published
To whom data/document is available
Scientific institutions
Under which criteria data/document could be used
Academic uses by faculty colleagues of universities in Iran or other universities in the world
From where data/document is obtainable
Email to the research officer at minoo.saeidi@gmail.com
What processes are involved for a request to access data/document
Email to the research officer And making decisions depending on the conditions and agreement