RECRUITING

Rectal Indomethacin vs Intravenous Ketorolac

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-11-07
Study Completion:2024-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05664074

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.

Ages Eligible for Study:6 Months to 21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Any patient undergoing ERCP (diagnostic or therapeutic with cannulation of the major or minor papilla)
  2. * Age 6 month- 21 years old
  3. * Does not meet exclusion criteria
  1. * \< 10 kg
  2. * Low risk subgroup: Biliary indication with history of prior biliary sphincterotomy.
  3. * High risk for bleeding (Example: Planned liver biopsy)
  4. * Gastrointestinal bleeding in previous 3 days
  5. * Acute pancreatitis (within 3 days) at the time of ERCP
  6. * Use of NSAIDs in the previous 5 days
  7. * Peptic ulcer disease
  8. * Acute kidney Injury or Known Chronic Kidney Disease per KDIGO
  9. * Pregnancy (Pregnancy tests are administered prior to ERCP as standard of care)
  10. * Lithium therapy
  11. * Allergy to ketorolac or indomethacin
  12. * Organ Dysfunction or SIRS

Contacts and Locations

Study Contact

Tyler Thompson, BS
CONTACT
513-517-1055
tyler.thompson@cchmc.org
Ethan Estes
CONTACT
513-803-4322
James.Estes@cchmc.org

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: David Vitale MD

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-07
Study Completion Date2024-06-01

Study Record Updates

Study Start Date2022-11-07
Study Completion Date2024-06-01

Terms related to this study

Additional Relevant MeSH Terms

  • Post-ERCP Acute Pancreatitis