Efficacy and Safety of Ondansetron versus Metoclopramide Treatment in Infants with Gastroesophageal Reflux Disease: A Comparative Study of Short Trial
Keywords:
Diarrhea, GERD, infant, ondansetron, metaclopramideAbstract
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.
References
1. Curien-Chotard M, Jantchou P. Natural history of gastroesophageal reflux in infancy: new data from a prospective cohort. BMC Pediatr. 2020; 20(1): 152. doi: 10.1186/s12887-020-02047-3.
2. Rybak A, Pesce M, Thapar N, Borrelli O. Gastroesophageal Reflux in Children. Int J Mol Sci. 2017; 18(8): 1671. doi: 10.3390/ijms18081671.
3. Kesavelu D, Franklyn N, Venkatraghavan C, Narayan D, P Ravindra K, Wasim A. Prevalence and Severity of Gastroesophageal Reflux Disease in Indian Children Presenting with Symptoms of Acid Reflux: A Real-world Evidence Study. Turk Arch Pediatr. 2025; 60(3): 341-343. doi: 10.5152/TurkArchPediatr.2025.24140.
4. Fernando T, Goldman RD. Management of gastroesophageal reflux disease in pediatric patients with cerebral palsy. Can Fam Physician. 2019 Nov; 65(11): 796-798.
5. Wickramasinghe N, Devanarayana NM. Insight into global burden of gastroesophageal reflux disease: Understanding its reach and impact. World J Gastrointest Pharmacol Ther. 2025; 16(1): 97918. doi: 10.4292/wjgpt.v16.i1.97918.
6. Chevalier I, Beck CE, Doré-Bergeron MJ, Orkin J. Medical management of gastroesophageal reflux in healthy infants. Paediatr Child Health. 2022; 27(8): 503-511. doi: 10.1093/pch/pxac068.
7. Tighe MP, Andrews E, Liddicoat I, Afzal NA, Hayen A, Beattie RM. Pharmacological treatment of gastro-oesophageal reflux in children. Cochrane Database Syst Rev. 2023; 8(8): CD008550. doi: 10.1002/14651858.CD008550.pub3.
8. Tan J, Jeffries S, Carr R. A Review of Histamine-2 Receptor Antagonist and Proton Pump Inhibitor Therapy for Gastroesophageal Reflux Disease in Neonates and Infants. Paediatr Drugs. 2023; 25(5): 557-576. doi: 10.1007/s40272-023-00580-z.
9. Razzaq A, Saleem S, Javed H. Domperidone and sudden cardiac death in the elderly due to ventricular arrhythmias in developing countries. J Pak Med Assoc. 2024; 74(9): 1727-1728. doi: 10.47391/JPMA.11377.
10. Ericson JE, Arnold C, Cheeseman J, Cho J, Kaneko S, Wilson E et al. Use and Safety of Erythromycin and Metoclopramide in Hospitalized Infants. J Pediatr Gastroenterol Nutr. 2015; 61(3): 334-9. doi: 10.1097/MPG.0000000000000792.
11. Li C, Cui W, Song P, Liu W, Wang X, Yang Q. Effect of ondansetron for preventing postoperative nausea and vomiting after breast cancer surgery. Am J Transl Res. 2022; 14(9): 6689-6695.
12. Zhong W, Shahbaz O, Teskey G, Beever A, Kachour N, Venketaraman V et al. Mechanisms of Nausea and Vomiting: Current Knowledge and Recent Advances in Intracellular Emetic Signaling Systems. Int J Mol Sci. 2021; 22(11): 5797. doi: 10.3390/ijms22115797.
13. Ahmad M, Rawat A, Farrukh S, Haq I, Kumar A, Mandal AK et al. Comparative Analysis of Oral Ondansetron, Metoclopramide, and Domperidone for Managing Vomiting in Children With Acute Gastroenteritis. Cureus. 2023; 15(10): e47611. doi: 10.7759/cureus.47611.
14. Barot KS, Vaghasiya KN, Suhagiya GH, Singh AP, Nadeem S, Qureshi AN et al. Comparing the Efficacy of Ondansetron, Domperidone, and Metoclopramide in Treating Vomiting in Pediatric Patients With Acute Gastroenteritis: A Network Meta-Analysis. Cureus. 2024; 16(8): e67902. doi: 10.7759/cureus.67902.
15. Khan A, Quratulain, Pervez H, Akhtar S, Inayatullah, Ullah Shah F. Efficacy of Single Dose Intravenous Ondansetron vs Metoclopramide in Children with Acute Gastroenteritis with Vomiting. Med Forum. 2023; 34(3): 80-84.
16. Al-Ansari K, Alomary S, Abdulateef H, Alshawagfa M, Kamal K. Metoclopramide versus ondansetron for the treatment of vomiting in children with acute gastroenteritis. J Pediatr Gastroenterol Nutr. 2011; 53(2): 156-60. doi: 10.1097/MPG.0b013e3182132d8d.
17. Sumie M, Nilimi N, Pankiv E, Hayes JA, Ayyama K, Yang A et al., Effect of ondansetron and Metoclopramide on postoperative nausea and vomiting in children undergoing tonsillectomy with or without adenoidectomy: a systematic review with meta-analysis. Jo Anesthes. 2025; 39(23): 1-10. doi: 10.1007/s00540-025-03463-4.
18. Taheri PA, Mahdianzadeh F, Shariat M, Sadeghi M. Combined therapy in gastroesophageal reflux disease of term neonates resistant to conservative therapy and monotherapy: a clinical trial. J Pediatr Neonat Individ Med. 2018; 7(2): e070201. doi: 10.7363/070201.
19. Afacan MA, Tayfur ?. Comparison of the Effects of Metoclopramide and Ondansetron on Emergency Service Observation Times in Acute Gastroenteritis-Related Nausea and Vomiting Cases. Sisli Etfal Hastan Tip Bul. 2019; 53(2): 186-189. doi: 10.14744/SEMB.2019.80217.
20. Hibbs AM, Lorch SA. Metoclopramide for the treatment of gastroesophageal reflux disease in infants: a systematic review. Pediatrics. 2006; 118(2): 746-52. doi: 10.1542/peds.2005-2664.
21. Rosen R, Vandenplas Y, Singendonk M, Cabana M, DiLorenzo C, Gottrand F et al. Pediatric Gastroesophageal Reflux Clinical Practice Guidelines: Joint Recommendations of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition and the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition. J Pediatr Gastroenterol Nutr. 2018; 66(3): 516-554. doi: 10.1097/MPG.0000000000001889.
22. Katz PO, Dunbar KB, Schnoll-Sussman FH, Greer KB, Yadlapati R, Spechler SJ. ACG Clinical Guideline for the Diagnosis and Management of Gastroesophageal Reflux Disease. Am J Gastroenterol. 2022; 117(1): 27-56. doi: 10.14309/ajg.0000000000001538.
23. Ge S, Mendley SR, Gerhart JG, Melloni C, Hornik CP, Sullivan JE et al. Population Pharmacokinetics of Metoclopramide in Infants, Children, and Adolescents. Clin Transl Sci. 2020; 13(6): 1189-1198. doi: 10.1111/cts.12803.
24. Kearns GL, van den Anker JN, Reed MD, Blumer JL. Pharmacokinetics of Metoclopramide in neonates. J Clin Pharmacol. 1998; 38(2): 122-8. doi: 10.1002/j.1552-4604.1998.tb04400.x.
25. Powell EC, Roskind CG, Schnadower D, Olsen CS, Casper TC, Tarr PI et al. Oral Ondansetron Administration in Children Seeking Emergency Department Care for Acute Gastroenteritis: A Patient-Level Propensity-Matched Analysis. Ann Emerg Med. 2022; 79(1): 66-74. doi: 10.1016/j.annemergmed.2021.06.003.
26. Slattery J, Quinten C, Candore G, Pinheiro L, Flynn R, Kurz X et al. Ondansetron use in nausea and vomiting during pregnancy: A descriptive analysis of prescription patterns and patient characteristics in UK general practice. Br J Clin Pharmacol. 2022; 88(10): 4526-4539. doi: 10.1111/bcp.15370.
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