NCT06898268

Efficacy and Safety of Ondansetron Versus Metaclopromide Treatment in Infants With Gastro Oesophageal Reflux

Efficacy and Safety of Ondansetron Versus Metaclopromide Treatment in Infants With Gastro Oesophageal Reflux, a Comparative Study of Short Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 290 (actual)
• Sponsor: Muhammad Aamir Latif · Academic / Other
• Sex: All
• Age: 1 Month – 12 Months
• Healthy volunteers: Not accepted

Summary

This study aimed to fill the gaps by comparing the efficacy and safety of ondansetron versus metoclopramide for the control of gastroesophageal reflux disorder in children 1-12 months of age, presenting at the outdoor department of Allama Iqbal Teaching Hospital, Dera Ghazi Khan.

Detailed description

Since the FDA issued a warning against domperidone as a potential proarrhythmic drug in children, its use has been widely discouraged and no longer recommended in safe practices. This warning at one end persuaded the pediatricians to search for the new options; on the other end, the use of metoclopramide, H2 receptor antagonists, and alginate-based medications became superfluous, opening a wide area of research in search of the next potential best option. The findings of this study would add to the existing statistics and help clinicians to have better outcomes among infants with gastroesophageal reflux disorder.

Conditions

• Gastroesophageal Reflux Disorder

Interventions

Type	Name	Description
DRUG	Metoclopramide	Patients were prescribed metoclopramide twice a day for one week.
DRUG	Ondansetron	Patients were put on oral ondansetron in BD doses for one week.

Timeline

• Start date: 2024-07-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2025-03-27
• Last updated: 2025-03-27

Locations

1 site across 1 country: Pakistan