Rectal Indomethacin vs Intravenous Ketorolac

Description

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

Study Overview

Study Details

Study overview

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.

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

Rectal Indomethacin vs Intravenous Ketorolac

Condition
Post-ERCP Acute Pancreatitis
Intervention / Treatment

-

Contacts and Locations

Cincinnati

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States, 45229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * \< 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

Ages Eligible for Study

6 Months to 21 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

David Vitale MD,

David Vitale, MD, PRINCIPAL_INVESTIGATOR, Children's Hospital Medical Center, Cincinnati

Study Record Dates

2024-06-01