Rectal Indomethacin vs Intravenous Ketorolac

NCT05664074 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 2022-0640
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (7)

• Post-ERCP Pancreatitis

  Below is the number of participants within the rectal indomethacin and IV ketorolac cohorts who developed Post-ERCP Pancreatitis- Post ERCP Pancreatitis: A patient must have at least 2 of the following to establish a diagnosis of post ERCP pancreatitis: 1. Characteristic physical exam findings- pain worse than admission per pain scales (please see point 2) and/or nausea 2. Amylase (unit/L) or lipase(unit/L) greater than 3 times the age appropriate upper limit of normal. * Normal range of amylase (15-127 unit/L) * Normal range of lipase (12-50 unit/L) 3. Confirmatory imaging (Ultrasound, CT or MRI) that suggests or demonstrates pancreatic inflammation

  2 weeks

• Post-ERCP Pancreatitis: Pancreatic Duct Injections

  86 participants from the rectal indomethacin cohort and 83 from IV ketorolac received pancreatic duct injections during their ERCP. Below we describe the outcome measure of post-ERCP pancreatitis vs. no pancreatitis for those who received pancreatic duct injections.

  2 weeks

• Post-ERCP Pancreatitis: Native Papilla

  36 participants from the rectal indomethacin cohort and 33 from IV ketorolac had a native papilla for their ERCP. Below we describe the outcome measure of post-ERCP pancreatitis vs. no pancreatitis for those who had a native papilla.

  2 weeks

• Post-ERCP Pancreatitis: Pancreatic Sphincterotomy

  25 participants from the rectal indomethacin cohort and 19 from IV ketorolac received pancreatic sphincterotomies during their ERCP. Below we describe the outcome measure of post-ERCP pancreatitis vs. no pancreatitis for those who received pancreatic sphincterotomies.

  2 weeks

• Post-ERCP Pancreatitis: Opti-Ray Amount

  83 participants from the rectal indomethacin cohort and 84 from IV ketorolac received various amounts of Opti-Ray during their ERCP. Below we describe the outcome measure of post-ERCP pancreatitis vs. no pancreatitis for those who received Opti-Ray.

  2 weeks

• Post-ERCP Pancreatitis: Therapeutic Pancreatic Duct Stent Placed

  51 participants from the rectal indomethacin cohort and 53 from IV ketorolac received a therapeutic pancreatic duct stent during their ERCP. Below we describe the outcome measure of post-ERCP pancreatitis vs. no pancreatitis for those who received therapeutic pancreatic duct stents.

  2 weeks

• Post-ERCP Pancreatitis: Prophylactic Pancreatic Duct Stent Placed

  11 participants from the rectal indomethacin cohort and 11 from IV ketorolac received a prophylactic pancreatic duct stent during their ERCP. Below we describe the outcome measure of post-ERCP pancreatitis vs. no pancreatitis for those who received prophylactic pancreatic duct stents.

  2 weeks

Secondary Outcomes (7)

• Pain Assessed by FLACC or NRS Scoring Post ERCP: PACU

  2 weeks

• Pain Assessed by FLACC or NRS Scoring Post ERCP: Evening

  2 weeks

• Pain Assessed by FLACC or NRS Scoring Post ERCP: Morning

  2 weeks

• Laboratory Markers Associated With PEP ( Lipase)

  2 weeks

• Laboratory Markers Associated With PEP (Amylase)

  2 weeks

Study Arms (2)

Rectal indomethacin

EXPERIMENTAL

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

Drug: Rectal indomethacin

IV ketorolac

EXPERIMENTAL

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

Drug: IV ketorolac

Interventions

Rectal indomethacin DRUG

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

Rectal indomethacin

IV ketorolac DRUG

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

IV ketorolac

Eligibility Criteria

• Age: 6 Months - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• \< 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

Sponsors & Collaborators

• David Vitale MD: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Interventions

Ketorolac

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. David Vitale
• Organization: Cincinnati Children's

David.Vitale@cchmc.org

(513) 517-7040

Study Officials

• David Vitale, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This will be a prospective study where patients will be randomized into either rectal indomethacin or IV ketorolac.

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: December 23, 2022
• Study Start: November 7, 2022
• Primary Completion: February 5, 2025
• Study Completion: February 5, 2025
• Last Updated: March 12, 2026
• Results First Posted: March 12, 2026

Record last verified: 2026-03

Locations

US (1)