Role of Proton Pump Inhibitor as Stress Ulcer Prophylaxis in Sick Children: A Randomized Controlled Trial
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Date
2025-06
Journal Title
Journal ISSN
Volume Title
Publisher
Indian Academy of Pediatrics
Abstract
OBJECTIVES To evaluate the efficacy of intravenous pantoprazole as a stress ulcer prophylaxis in sick children to prevent gastrointes?nal (GI) bleeding. METHODS A randomized controlled trial included children aged one-month to 18 years requiring intensive care. Par?cipants were randomly assigned to receive intravenous pantoprazole or a placebo (normal saline) daily. The primary outcome was the incidence of GI bleeding (clinically significant or overt). Secondary outcomes were the median ?me of onset of GI bleeding, incidence of ven?lator- associated pneumonia (VAP), dura?on of hospitaliza?on, organ dysfunc?on scores, and all-cause mortality. RESULTS A total of 151 and 150 children were allocated to group A (pantoprazole) and group B (placebo), respec?vely. No significant difference was observed in the incidence of GI bleeding between the groups (group A: 21/151 vs group B: 19/150 [RR (95% CI) 1.03 (0.18, 5.82), P = 0.985]. Comparable results were observed for clinically significant GI bleeding (1.3% vs 0.6%; RR (95% CI) 0.54 (0.21, 1.28); P = 0.653 and overt GI bleeding [12.6% vs 12%; RR (95% CI) 0.98 (0.39, 2.23); P value = 0.313]. On mul?variate analysis, there was a reduced incidence of GI bleeding in children with coagulopathy in pantoprazole group ( n = 29) as compared to placebo ( n = 25) [RR (95%CI) 0.52 (0.32, 0.87); P = 0.022]. CONCLUSION Among cri?cally ill children, pantoprazole prophylaxis did not reduce the incidence of gastrointes?nal bleeding, although, a notable decrease in gastrointes?nal bleeding was observed in children with coagulopathy.
Description
Keywords
Critically ill children, PPI, Stress ulcer prophylaxis, Pantoprazole, GI bleeding
Citation
Kavilapurapu Ananya, Lalitha AV, Ghosh Santu . Role of Proton Pump Inhibitor as Stress Ulcer Prophylaxis in Sick Children: A Randomized Controlled Trial. Indian Pediatrics. 2025 Jun; 62(6): 407-413