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Rectal Indomethacin vs Intravenous Ketorolac

NCT05664074 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2026-03-12

Study results available
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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.

Conditions

  • Post-ERCP Acute Pancreatitis

Interventions

DRUG

Rectal indomethacin

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

DRUG

IV ketorolac

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

Sponsors & Collaborators

  • David Vitale MD

    lead OTHER

Principal Investigators

  • David Vitale, MD · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-07
Primary Completion
2025-02-05
Completion
2025-02-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05664074 on ClinicalTrials.gov