CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 192 enrolled
Drug / intervention
Rectal indomethacin +1 moredrug
Likely dose
Rectal indomethacin 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05664074
NCT05664074Phase 4Completed
CompareCT.gov

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

David Vitale MD·interventional·Posted Dec 23, 2022·Updated Mar 12, 2026

In Brief

A Phase 4 clinical trial evaluating Rectal indomethacin and IV ketorolac for Post-ERCP Acute Pancreatitis. Completed, enrolled 192 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPost-ERCP Acute Pancreatitis
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2023202420252026
First PostedDec 23, 2022
Enrollment StartNov 7, 2022
Primary CompletionFeb 5, 2025
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 3.5 years ago

Interventions

Rectal indomethacindrug

Dosage based on subject's weight: \>=50 kg, 100 mg; 30-49 kg, 50 mg; 10-29 kg, 25 mg

IV ketorolacdrug

Dosage based on subject's weight: 0.5 mg/kg (maximum: 15 mg)