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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
290
Patients were prescribed metoclopramide twice a day for one week.
Patients were put on oral ondansetron in BD doses for one week.
Allama Iqbal Teaching Hospital
Dera Ghazi Khan, Punjab Province, Pakistan
Response to treatment
Reduction in vomiting episodes and preservation/increase in previous weight
Time frame: 1 week
Treatment-emerged adverse events
The occurrence of diarrhea, constipation, lethargy/somnolence, dark urine, headache, and warm flushes was considered as treatment-emerged adverse events.
Time frame: 1 week
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