Rectal Indomethacin vs Intravenous Ketorolac

• Status: Recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: David Vitale
• Treatments: Indomethacin; Ketorolac

Criteria

Inclusion Criteria:

• Any patient undergoing ERCP (diagnostic or therapeutic with cannulation of the major or minor papilla)

• Age 6 month- 21 years old

• Does not meet exclusion criteria

Exclusion Criteria:

• < 10 kg

• Low risk subgroup: Biliary indication with history of prior biliary sphincterotomy.

• High risk for bleeding (Example: Planned liver biopsy)

• Gastrointestinal bleeding in previous 3 days

• Acute pancreatitis (within 3 days) at the time of ERCP

• Use of NSAIDs in the previous 5 days

• Peptic ulcer disease

• Acute kidney Injury or Known Chronic Kidney Disease per KDIGO

• Pregnancy (Pregnancy tests are administered prior to ERCP as standard of care)

• Lithium therapy

• Allergy to ketorolac or indomethacin

• Organ Dysfunction or SIRS