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

Muhammad Aamir Latif

Status: Completed

Conditions: Gastroesophageal Reflux Disorder

Treatments: Drug: Ondansetron; Drug: Metoclopramide

Study type: Interventional

Funder types: Other

Identifiers

NCT06898268

DRIRUMDGKHAN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 290 patients

Sex: All

Ages: 1 to 12 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

290 participants in 2 patient groups

Metoclopramide group

Experimental group

Description:

Patients were prescribed metoclopramide twice a day for one week.

Treatment:

Drug: Metoclopramide

Ondansetron

Experimental group

Description:

Patients in this group were put on oral ondansetron in BD doses for one week.

Treatment:

Drug: Ondansetron