Efficacy and Safety of Ondansetron versus Metoclopramide Treatment in Infants with Gastroesophageal Reflux Disease: A Comparative Study of Short Trial

OBJECTIVE: To compare the efficacy and safety of ondansetron versus Metoclopramide in infants with gastroesophageal reflux disease (GERD).METHODOLOGY: This single-centre, randomized controlled trial was conducted at the Pediatric Medicine outpatient department, Allama Iqbal Teaching Hospital, Dera Ghazi Khan, from July to December 2024.Infants aged 1-12 months with GERD refractory to conservative management were randomized (1:1) to receive oral Metoclopramide or ondansetron for one week.Eligible infants were enrolled using a simple random sampling technique.Diagnosis was based on clinical history and exclusion of hypertrophic pyloric stenosis by ultrasound.Treatment response (70% reduction in vomiting episodes and weight preservation/gain) and adverse events were assessed at follow-up.Data were analyzed using SPSS v26.0, with p<0.05 considered statistically significant.RESULTS: Of 284 enrolled infants, 154 (54.2%) were male.The median age was 7.00 (IQR 4.00-10.00)months.Rural residence was noted in 200 (70.4%)infants, and exclusive breastfeeding in 144 (50.7%).A total of 271 infants (95.4%) completed follow-up (Metoclopramide: n=136, ondansetron: n=135).Treatment response occurred in 225 (83.0%) infants, with no significant difference between metoclopramide (79.4%) and ondansetron (86.7%) groups (p=0.112).Adverse events were relatively similar between groups for diarrhea (20.6% vs 22.2%, p=0.743) and lethargy (10.3% vs 11.9%, p=0.683).Warm flushes (5.9%) and constipation (2.2%) were observed only with ondansetron.CONCLUSION: In infants with GERD, ondansetron appears to offer acceptable efficacy, reinforcing its position as a preferred agent where resources permit.Metoclopramide remains an appropriate alternative, particularly in settings where access or cost are significant considerations.