Ondansetron Versus Domperidone for Treating Vomiting in Acute Gastroenteritis in Children

Acute Gastroenteritis Clinical Trial

Official title:

Comparison of Ondansetron Versus Domperidone for Treating Vomiting in Acute Gastroenteritis in Children At a Resource Limited Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05076461
• Other study ID #: TehsilHeadquarter
• Status: Completed
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: September 2021
• Source: Tehsil Headquarter Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Gastroenteritis
• Gastroenteritis
• Vomiting
• Vomiting in Infants and/or Children

Intervention

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

Locations

Country	Name	City	State
Pakistan	Tehsil Headquarter Hospital	Liaquatpur	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Tehsil Headquarter Hospital

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 hours