Back to resultsOndansetron Versus Domperidone for Treating Vomiting in Acute Gastroenteritis in Children
Primary Purpose
Vomiting in Infants and/or Children, Acute Gastroenteritis
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Ondansetron
Sponsored by
About this trial
This is an interventional treatment trial for Vomiting in Infants and/or Children
Eligibility Criteria
Inclusion Criteria:
- Children of both genders aged below 12 years of age having 3 or more non-bilious, non-bloody vomiting episodes within 24 hours and with suggestive signs and symptoms of Acte Gastroenteritis.
Exclusion Criteria:
- Children who took any kinds of antiemetic in the last 6 hours of presentation of emergency department.
- Children having chronic liver disease, chronic kidney disease or congenital heart disease, neurological disorders, any kinds of malignancy, severe dehydration (requiring intravenous fluid replacement), severe acute malnutrition (weight-for-height below -3 standard deviation (SD) adopting WHO child growth protocols) or history known to allergy to antiemetics.
Sites / Locations
- Tehsil Headquarter Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
ondansetron group
Domperidone group
Arm Description
Children in ondansetron group received oral suspension of ondansetron as 0.15mg per body weight
Children in domperidone group, oral suspension of domperidone was given as 0.5 mg per kg body weight
Outcomes
Primary Outcome Measures
Cessation of vomiting
Children in ondansetron group received oral suspension of ondansetron as 0.15mg per body weight while in domperidone group, oral suspension of domperidone was given as 0.5 mg per kg body weight. Children in both study groups were administered designated drugs in the emergency department. Children were observed in the emergency department for 6-hours and discharged if they were vomiting free. All children were asked to follow up after 24 hours for the assessment of the effectiveness of the treatment for cessation of vomiting.
Secondary Outcome Measures
Full Information
NCT ID
NCT05076461
First Posted
September 15, 2021
Last Updated
September 30, 2021
Sponsor
Tehsil Headquarter Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05076461
Brief Title
Ondansetron Versus Domperidone for Treating Vomiting in Acute Gastroenteritis in Children
Official Title
Comparison of Ondansetron Versus Domperidone for Treating Vomiting in Acute Gastroenteritis in Children At a Resource Limited Setting
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tehsil Headquarter Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Most of the trials conducted comparing ondansetron and domperidone have been conducted among children aged below 5 or 6 years of age while no study from Pakistan has compared efficacy of these antiemetic agents among children up to 12 years of age. The findings of present study will give valuable evidence about the effectiveness of these antiemetic agents to prevent vomiting among children suffering with acute gastroenteritis at a resource limited setting of South Punjab, Pakistan.
Detailed Description
to compare the efficacy of ondansetron versus domperidone for treating vomiting in acute gastroenteritis in children at a resource limited emergency setting of South Punjab, Pakistan.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vomiting in Infants and/or Children, Acute Gastroenteritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ondansetron group
Arm Type
Experimental
Arm Description
Children in ondansetron group received oral suspension of ondansetron as 0.15mg per body weight
Arm Title
Domperidone group
Arm Type
Experimental
Arm Description
Children in domperidone group, oral suspension of domperidone was given as 0.5 mg per kg body weight
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Intervention Description
Ondansetron group received oral suspension of ondansetron as 0.15mg per body weight
Primary Outcome Measure Information:
Title
Cessation of vomiting
Description
Children in ondansetron group received oral suspension of ondansetron as 0.15mg per body weight while in domperidone group, oral suspension of domperidone was given as 0.5 mg per kg body weight. Children in both study groups were administered designated drugs in the emergency department. Children were observed in the emergency department for 6-hours and discharged if they were vomiting free. All children were asked to follow up after 24 hours for the assessment of the effectiveness of the treatment for cessation of vomiting.
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Children of both genders aged below 12 years of age having 3 or more non-bilious, non-bloody vomiting episodes within 24 hours and with suggestive signs and symptoms of Acte Gastroenteritis.
Exclusion Criteria:
Children who took any kinds of antiemetic in the last 6 hours of presentation of emergency department.
Children having chronic liver disease, chronic kidney disease or congenital heart disease, neurological disorders, any kinds of malignancy, severe dehydration (requiring intravenous fluid replacement), severe acute malnutrition (weight-for-height below -3 standard deviation (SD) adopting WHO child growth protocols) or history known to allergy to antiemetics.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tauseef Ahmad, MBBS
Organizational Affiliation
Tehsil Headquarter Hospital, Liaquatpur, Pakistan.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tehsil Headquarter Hospital
City
Liaquatpur
State/Province
Punjab
ZIP/Postal Code
64000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Ondansetron Versus Domperidone for Treating Vomiting in Acute Gastroenteritis in Children
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