Rectal Indomethacin vs Intravenous Ketorolac

David Vitale MD

Status and phase: Enrolling; Phase 4

Conditions: Post-ERCP Acute Pancreatitis

Treatments: Drug: Rectal indomethacin; Drug: IV ketorolac

Study type: Interventional

Funder types: Other

Identifiers

NCT05664074

2022-0640

Details and patient eligibility

About

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.

Enrollment: 192 estimated patients

Sex: All

Ages: 6 months to 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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192 participants in 2 patient groups

Rectal indomethacin

Experimental group

Description:

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

Treatment:

Drug: Rectal indomethacin

IV ketorolac

Experimental group

Description:

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

Treatment:

Drug: IV ketorolac