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Completed

NCT Number: NCT05076461

Ondansetron Versus Domperidone for Treating Vomiting in Acute Gastroenteritis in Children

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.

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Key information

Conditions

Vomiting in Infants and/or Children Acute Gastroenteritis

Age range

1 day–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tehsil Headquarter Hospital

Liaquatpur, Punjab Province, 64000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ondansetron

Drug

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Tehsil Headquarter Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 13, 2021
Registry last updated
Oct 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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