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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

290 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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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

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Gastroesophageal Reflux Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Metoclopramide group

Patients were prescribed metoclopramide twice a day for one week.

Group Type EXPERIMENTAL

Metoclopramide

Intervention Type DRUG

Patients were prescribed metoclopramide twice a day for one week.

Ondansetron

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

Group Type EXPERIMENTAL

Ondansetron

Intervention Type DRUG

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

Interventions

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Metoclopramide

Patients were prescribed metoclopramide twice a day for one week.

Intervention Type DRUG

Ondansetron

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

1 Month

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No