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

Not Applicable

Completed

• Conditions: Gastroesophageal Reflux Disorder
• Interventions: Drug: Metoclopramide; Drug: Ondansetron

• Registration Number: NCT06898268
• Lead Sponsor: Muhammad Aamir Latif

Brief 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.

Study Timeline

• Study Start: 2024-07-01
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-03
• Study First Submitted: 2025-03-22
• Study First Submitted QC: 2025-03-22
• Last Update Submitted: 2025-03-22
• Study First Posted: 2025-03-27
• Last Update Posted: 2025-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 290

Inclusion Criteria

• Infants of any gender
• Aged 1-12 months
• Presenting with symptoms of gastroesophageal reflux disease not responding to dietary modifications and positioning
• Afebrile at the time of presentation
• Vitally stable

Exclusion Criteria

• No evidence of hypertrophic pyloric stenosis on ultrasonography
• Children with congenital heart disease
• Any history of prior illness associated with symptoms
• With abdominal distension
• Neurological impairment, like developmentally delayed, grossly microcephalic

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metoclopramide group	Metoclopramide	Patients were prescribed metoclopramide twice a day for one week.
Ondansetron	Ondansetron	Patients in this group were put on oral ondansetron in BD doses for one week.

Primary Outcome Measures

Name	Time	Method
Response to treatment	1 week	Reduction in vomiting episodes and preservation/increase in previous weight
Treatment-emerged adverse events	1 week	The occurrence of diarrhea, constipation, lethargy/somnolence, dark urine, headache, and warm flushes was considered as treatment-emerged adverse events.

Trial Locations

Locations (1)

Allama Iqbal Teaching Hospital; 🇵🇰 Dera Ghazi Khan, Punjab, Pakistan