NCT05664074

Rectal Indomethacin vs Intravenous Ketorolac

Post ERCP Pancreatitis Prophylaxis, Effectiveness of Rectal Indomethacin vs Intravenous Ketorolac in the Pediatric Population

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 192 (actual)
• Sponsor: David Vitale MD · Academic / Other
• Sex: All
• Age: 6 Months – 21 Years
• Healthy volunteers: Not accepted

Summary

Endoscopic retrograde cholangiopancreatography (ERCP) is an essential procedure that can be complicated by post-ERCP pancreatitis (PEP). Indomethacin and ketorolac are two medications used to prevent PEP. The main reason for this research study is to compare the effectiveness these drugs at reducing rates of PEP. There have been no studies comparing the effectiveness of these medications in preventing PEP in pediatric patients. You are being asked to take part in this research study because you are scheduled to have an ERCP as part of your medical care.

Conditions

• Post-ERCP Acute Pancreatitis

Interventions

Type	Name	Description
DRUG	Rectal indomethacin	Dosage based on subject's weight: \>=50 kg, 100 mg; 30-49 kg, 50 mg; 10-29 kg, 25 mg
DRUG	IV ketorolac	Dosage based on subject's weight: 0.5 mg/kg (maximum: 15 mg)

Timeline

• Start date: 2022-11-07
• Primary completion: 2025-02-05
• Completion: 2025-02-05
• First posted: 2022-12-23
• Last updated: 2026-03-12
• Results posted: 2026-03-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study