Post ERCP Pancreatitis Prophylaxis, Effectiveness of Rectal Indomethacin vs Intravenous Ketorolac in the Pediatric Population
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 21
Healthy Volunteers: f
View:
• 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
Locations
United States
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Contact Information
Primary
Tyler Thompson, BS
tyler.thompson@cchmc.org
513-517-1055
Backup
Ethan Estes
James.Estes@cchmc.org
513-803-4322
Time Frame
Start Date: 2022-11-07
Estimated Completion Date: 2025-06-01
Participants
Target number of participants: 192
Treatments
Experimental: Rectal indomethacin
Dosage based on subject's weight:~\>=50 kg, 100 mg; 30-49 kg, 50 mg; 10-29 kg, 25 mg
Experimental: IV ketorolac
Dosage based on subject's weight: 0.5 mg/kg (maximum: 15 mg)
Related Therapeutic Areas
Sponsors
Leads: David Vitale MD