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Recruiting
NCT05664074
Rectal Indomethacin vs Intravenous Ketorolac
Conditions: Post-ERCP Acute Pancreatitis
Sex: All
Ages: 6 Months – 21 Years
Phase: PHASE4
Enrollment: 192
Sponsor: David Vitale
Location: United States
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 Criteria
Inclusion Criteria:Any patient undergoing ERCP (diagnostic or therapeutic with cannulation of the major or minor papilla)Age 6 month- 21 years oldDoes not meet exclusion criteriaExclusion Criteria:< 10 kgLow risk subgroup: Biliary indication with history of prior biliary sphincterotomy.High risk for bleeding (Example: Planned liver biopsy)Gastrointestinal bleeding in previous 3 daysAcute pancreatitis (within 3 days) at the time of ERCPUse of NSAIDs in the previous 5 daysPeptic ulcer diseaseAcute kidney Injury or Known Chronic Kidney Disease per KDIGOPregnancy (Pregnancy tests are administered prior to ERCP as standard of care)Lithium therapyAllergy to ketorolac or indomethacinOrgan Dysfunction or SIRS
Source: ClinicalTrials.gov (NCT05664074). StuddyBuddy aggregates publicly available trial information.