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Role of Proton Pump Inhibitor as Stress Ulcer Prophylaxis in Sick Children: A Randomized Controlled Trial
Ananya Kavilapurapu1, A V Lalitha2, Santu Ghosh3
1Department of Pediatric Critical Care, St. John's Medical College and Hospital, Bengaluru, Karnataka, India.
Insights
Intravenous pantoprazole did not significantly reduce gastrointestinal bleeding in critically ill children. However, it showed a notable decrease in bleeding for those with coagulopathy.
Area of Science:
- Pediatric Critical Care Medicine
- Gastroenterology
- Pharmacology
Background:
- Stress ulcer prophylaxis is crucial in critically ill children to prevent gastrointestinal (GI) bleeding.
- Proton pump inhibitors like pantoprazole are commonly used, but their efficacy in pediatric intensive care settings requires further evaluation.
Purpose of the Study:
- To assess the effectiveness of intravenous pantoprazole in preventing GI bleeding among critically ill children.
- To identify potential benefits in specific subgroups, such as those with coagulopathy.
Main Methods:
- A randomized controlled trial involving children aged one month to 18 years requiring intensive care.
- Participants received daily intravenous pantoprazole or a placebo (normal saline).
- Primary outcome: incidence of GI bleeding (clinically significant or overt); Secondary outcomes: VAP, hospitalization duration, mortality.
Main Results:
- No significant difference in overall GI bleeding incidence between pantoprazole and placebo groups (21/151 vs 19/150).
- Similar rates for clinically significant and overt GI bleeding between the groups.
- A statistically significant reduction in GI bleeding was observed in children with coagulopathy receiving pantoprazole (RR 0.52; P=0.022).
Conclusions:
- Intravenous pantoprazole did not demonstrate efficacy in reducing overall GI bleeding in critically ill children.
- Pantoprazole may offer a protective effect against GI bleeding in pediatric patients with coagulopathy.
Objective:
To evaluate the efficacy of intravenous pantoprazole as a stress ulcer prophylaxis in sick children to prevent gastrointestinal (GI) bleeding.
Methods:
A randomized controlled trial included children aged one-month to 18 years requiring intensive care. Participants 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 time of onset of GI bleeding, incidence of ventilator-associated pneumonia (VAP), duration of hospitalization, organ dysfunction scores, and all-cause mortality.
Results:
A total of 151 and 150 children were allocated to group A (pantoprazole) and group B (placebo), respectively. 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 multivariate 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 critically ill children, pantoprazole prophylaxis did not reduce the incidence of gastrointestinal bleeding, although, a notable decrease in gastrointestinal bleeding was observed in children with coagulopathy.
Trials Registry:
Clinical Trials Registry of India, Ref no: CTRI/2021/08/035785, Date of registration:18th August 2021.
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