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COMPLETEDPHASE4

Rectal Indomethacin vs Intravenous Ketorolac

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

NCT05664074•David Vitale MD

View on ClinicalTrials.gov

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.

Eligibility

Age

0 - 21 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Any patient undergoing ERCP (diagnostic or therapeutic with cannulation of the major or minor papilla)
•Age 6 month- 21 years old

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
+2 more criteria

Locations (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Key Dates

Start Date

November 7, 2022

Primary Completion Date

February 5, 2025

Completion Date

February 5, 2025

Last Updated

March 12, 2026

Enrollment

192

ACTUAL participants

Conditions

Post-ERCP Acute Pancreatitis

Interventions

Rectal indomethacin

DRUG

IV ketorolac

DRUG

ERCP-induced and Non-ERCP Induced Acute Pancreatitis: Two Distinct Clinical and Immunological Entities?

NCT02602574

Post-ERCP Acute Pancreatitis

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COMPLETED

Short Term Pancreatic Stenting Registry

NCT02262845

Post-ERCP Acute PancreatitisPancreatic Duct Stricture+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Rectal Indomethacin vs Intravenous Ketorolac

Inclusion Criteria

Exclusion Criteria

ERCP-induced and Non-ERCP Induced Acute Pancreatitis: Two Distinct Clinical and Immunological Entities?

Short Term Pancreatic Stenting Registry

A Prospective Trial of Aggressive Hydration Strategy to Reduce Post-ERCP Pancreatitis