drugset / Trial / NCT05664074

Rectal Indomethacin vs Intravenous Ketorolac

NCT05664074

Phase 4 Completed 192 enrolled David Vitale MD
RandomizedParallel-groupSingle-blindPrevention

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.

Timeline

Start
2022-11-07
Primary completion
2025-02-05
Completion
2025-02-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Indomethacin Small molecule 25 mg Rectal
Subject Indomethacin Small molecule 50 mg Rectal
Subject Indomethacin Small molecule 100 mg Rectal
Subject Ketorolac Other / unclassified 0.5 mg/kg Intravenous

Indications