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Ondansetron Versus Domperidone for Treating Vomiting in Acute Gastroenteritis in Children

T

Tehsil Headquarter Hospital

Status

Completed

Conditions

Vomiting in Infants and/or Children
Acute Gastroenteritis

Treatments

Drug: Ondansetron

Study type

Interventional

Funder types

Other

Identifiers

NCT05076461
TehsilHeadquarter

Details and patient eligibility

About

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 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.

Enrollment

300 patients

Sex

All

Ages

1 day to 12 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

300 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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