Ondansetron Versus Domperidone for Treating Vomiting in Acute Gastroenteritis in Children

NCT05076461 | Completed

• 1 other identifier: TehsilHeadquarter
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Vomiting in Infants and/or Children; Acute Gastroenteritis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

ondansetron group

EXPERIMENTAL

Children in ondansetron group received oral suspension of ondansetron as 0.15mg per body weight

Drug: Ondansetron

Domperidone group

EXPERIMENTAL

Children in domperidone group, oral suspension of domperidone was given as 0.5 mg per kg body weight

Drug: Ondansetron

Interventions

Ondansetron DRUG

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

Domperidone group; ondansetron group

Eligibility Criteria

• Age: 1 Day - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tehsil Headquarter Hospital: lead

Study Sites (1)

Tehsil Headquarter Hospital

Liaquatpur, Punjab Province, 64000, Pakistan

Location

MeSH Terms

Interventions

Ondansetron

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Tauseef Ahmad, MBBS

  Tehsil Headquarter Hospital, Liaquatpur, Pakistan.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: October 13, 2021
• Study Start: July 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: October 13, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)