Ondansetron Versus Domperidone for Treating Vomiting in Acute Gastroenteritis in Children

Not Applicable

Completed

• Conditions: Vomiting in Infants and/or Children; Acute Gastroenteritis
• Interventions: Drug: Ondansetron

• Registration Number: NCT05076461
• Lead Sponsor: Tehsil Headquarter Hospital

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.

Study Timeline

• Study Start: 2020-07-01
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Status Verified: 2021-09
• Study First Submitted: 2021-09-15
• Study First Submitted QC: 2021-09-30
• Last Update Submitted: 2021-09-30
• Study First Posted: 2021-10-13
• Last Update Posted: 2021-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ondansetron group	Ondansetron	Children in ondansetron group received oral suspension of ondansetron as 0.15mg per body weight
Domperidone group	Ondansetron	Children in domperidone group, oral suspension of domperidone was given as 0.5 mg per kg body weight

Primary Outcome Measures

Name	Time	Method
Cessation of vomiting	24 hours	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.

Trial Locations

Locations (1)

Tehsil Headquarter Hospital; 🇵🇰 Liaquatpur, Punjab, Pakistan