Comparing rectal indomethacin and intravenous ketorolac for preventing pancreatitis after ERCP
Post ERCP Pancreatitis Prophylaxis, Effectiveness of Rectal Indomethacin vs Intravenous Ketorolac in the Pediatric Population
This study is testing whether a rectal medication or an intravenous one can better prevent pancreatitis in kids and young adults after a specific procedure called ERCP.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 192 (estimated) |
| Ages | 6 Months to 21 Years |
| Sex | All |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Locations | 1 site (Cincinnati, Ohio) |
| Trial ID | NCT05664074 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of rectal indomethacin versus intravenous ketorolac in preventing post-ERCP acute pancreatitis in pediatric patients aged 6 months to 21 years. Participants scheduled for an ERCP procedure will be randomly assigned to receive one of the two medications to assess which is more effective at reducing the incidence of pancreatitis following the procedure. The study focuses on a population that has not been previously studied in this context, making it a novel approach to addressing a significant complication of ERCP.
Who should consider this trial
Good fit: Ideal candidates for this study are pediatric patients aged 6 months to 21 years who are scheduled to undergo an ERCP.
Not a fit: Patients who are under 10 kg, have a history of biliary sphincterotomy, or have certain medical conditions such as acute pancreatitis or gastrointestinal bleeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective medication option for preventing pancreatitis in children undergoing ERCP.
How similar studies have performed: There have been no prior studies comparing the effectiveness of rectal indomethacin and intravenous ketorolac specifically for preventing post-ERCP pancreatitis in pediatric patients, making this a novel investigation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cincinnati, Ohio
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: David Vitale, MD — Children's Hospital Medical Center, Cincinnati
- Study coordinator: Tyler Thompson, BS
- Email: tyler.thompson@cchmc.org
- Phone: 513-517-1055
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.