Ondansetron Versus Domperidone for Treating Vomiting in Acute Gastroenteritis in Children

Overview

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.

Full Title of Study: “Comparison of Ondansetron Versus Domperidone for Treating Vomiting in Acute Gastroenteritis in Children At a Resource Limited Setting”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: June 30, 2021

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.

Interventions

• Drug: Ondansetron
  • Ondansetron group received oral suspension of ondansetron as 0.15mg per body weight

Arms, Groups and Cohorts

• Experimental: ondansetron group
  • Children in ondansetron group received oral suspension of ondansetron as 0.15mg per body weight
• Experimental: Domperidone group
  • Children in domperidone group, oral suspension of domperidone was given as 0.5 mg per kg body weight

Clinical Trial Outcome Measures

Primary Measures

• Cessation of vomiting
  • Time Frame: 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 1 Day

Maximum Age: 12 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • Tehsil Headquarter Hospital
• Provider of Information About this Clinical Study
  • Principal Investigator: Dr. Tauseef Ahmad, Principal Investigator – Tehsil Headquarter Hospital
• Overall Official(s)
  • Tauseef Ahmad, MBBS, Principal Investigator, Tehsil Headquarter Hospital, Liaquatpur, Pakistan.