Rectal Indomethacin vs Intravenous Ketorolac

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-07

Study Completion Date

2025-06-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Post-ERCP Acute Pancreatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Rectal indomethacin

Dosage based on subject's weight:

\>=50 kg, 100 mg; 30-49 kg, 50 mg; 10-29 kg, 25 mg

Group Type EXPERIMENTAL

Rectal indomethacin

Intervention Type DRUG

Dosage based on subject's weight:

\>=50 kg, 100 mg; 30-49 kg, 50 mg; 10-29 kg, 25 mg

IV ketorolac

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

Group Type EXPERIMENTAL

IV ketorolac

Intervention Type DRUG

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

Interventions

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Rectal indomethacin

Dosage based on subject's weight:

\>=50 kg, 100 mg; 30-49 kg, 50 mg; 10-29 kg, 25 mg

Intervention Type DRUG

IV ketorolac

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

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

Minimum Eligible Age

6 Months

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No