Histamine-2 Receptor Antagonist for Gastric Bleeding Prophylaxis in Low-Risk Critically Ill Children: A Randomized Trial of Ranitidine

Background: Stress-related mucosal disease (SRMD) is a significant concern in critically ill children, potentially leading to gastric bleeding. Prophylaxis with histamine-2 receptor antagonists (H2RAs) like ranitidine is common, yet its efficacy, particularly in children with a lower severity of illness, remains a subject of intense debate and investigation. Methods: A single-center, prospective, randomized controlled trial was conducted in the Pediatric Intensive Care Unit (PICU) of Dr. M. Djamil General Hospital, Padang, Indonesia, between October 2024 and January 2025. Sixty critically ill children, aged 1 month to 18 years, were randomly assigned to receive either intravenous ranitidine (1 mg/kg/dose twice daily) or standard supportive care (control group) for five days. The primary outcome was the incidence of gastric bleeding, identified by the presence of fresh or "coffee-ground" material in nasogastric tube aspirate. Results: A total of 60 patients were analyzed (30 per group). The cohort was predominantly composed of infants (60.0%) with respiratory distress as the primary diagnosis. Gastric bleeding occurred in one patient (3.3%) in the ranitidine group and three patients (10.0%) in the control group. The relative risk for bleeding with ranitidine was 0.33 (95% CI: 0.316–32.889). This observed difference was not statistically significant (p > 0.05). A notable characteristic of the cohort was a low baseline severity of illness; 76.7% of the intervention group and 63.3% of the control group had a Phoenix Sepsis Score below 2, indicating a non-septic state. No adverse effects from ranitidine were reported. Conclusion: In this cohort of predominantly low-risk critically ill children, ranitidine prophylaxis did not significantly reduce the incidence of gastric bleeding. These findings lend strong support to the concept that a routine, one-size-fits-all approach to stress ulcer prophylaxis may be unnecessary and not beneficial in pediatric patient populations with a low burden of critical illness, underscoring the paramount importance of risk stratification in clinical decision-making.