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Ondansetron Versus Domperidone for Treating Vomiting in Acute Gastroenteritis in Children

NCT ID: NCT05076461

Last Updated: 2021-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2021-06-30

Brief Summary

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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

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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.

Conditions

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Vomiting in Infants and/or Children Acute Gastroenteritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ondansetron group

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

Group Type EXPERIMENTAL

Ondansetron

Intervention Type DRUG

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

Domperidone group

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

Group Type EXPERIMENTAL

Ondansetron

Intervention Type DRUG

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

Interventions

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Ondansetron

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

1 Day

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tehsil Headquarter Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr. Tauseef Ahmad

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tauseef Ahmad, MBBS

Role: PRINCIPAL_INVESTIGATOR

Tehsil Headquarter Hospital, Liaquatpur, Pakistan.

Locations

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Tehsil Headquarter Hospital

Liaquatpur, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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TehsilHeadquarter

Identifier Type: -

Identifier Source: org_study_id