A Randomized Controlled Trial of IV Ketorolac to Prevent Post-ERCP Pancreatitis

Study Overview
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Brief Summary
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Determine if IV ketorolac is an effective agent in the prevention of post-ERCP pancreatitis. Determine if IV ketorolac provides improved post-procedure analgesia. Determine if systemic mediators of inflammation are reduced in patients receiving IV ketorolac following ERCP.

Detailed Description
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Acute pancreatitis is the most common major complication of both diagnostic and therapeutic endoscopic retrograde cholangiopancreatography (ERCP), accounting for substantial morbidity and an annual expenditure of approximately 150 million annually.(1,2) Non-steroidal anti-inflammatory agents (NSAIDs) have been shown to be effective in multiple prospective randomized controlled trial for the prevention of post-ERCP pancreatitis.(3-6) NSAIDs are postulated to inhibit phospholipase A2 and prostaglandin synthesis, which plays an important role in the inflammatory cascade in acute pancreatitis. Rectal suppository indomethacin (a potent COX-2 inhibitor) has been effective in preventing post-ERCP pancreatitis in clinical trials and is now recommended for routine use for ERCP by the European Society of Gastrointestinal Endoscopy.(7) Toradol® (ketorolac), an NSAID available in IV form, is a more potent COX-2 inhibitor and analgesic than indomethacin.(8,9) Ketorolac is routinely used postoperatively following major surgery to assist in pain control particularly following orthopedic procedures. IV ketorolac has never been evaluated for the prevention of post-ERCP pancreatitis.

Official Title
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A Randomized Controlled Trial of IV Ketorolac to Prevent Post-ERCP Pancreatitis

Conditions
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Pancreatitis

Intervention / Treatment
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* Drug: Ketorolac
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients presenting to SFGH for ERCP Age 18-85 Do not meet exclusion criteria Exclusion Criteria: Acute pancreatitis at the time of ERCP Use of NSAIDs in the previous week Peptic ulcer disease Severe renal dysfunction Pregnancy Lithium therapy allergy to ketorolac

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Normal Saline will be administered prior to procedure. | Drug: Placebo<br>* Intravenous saline<br>|
| Active Comparator: Toradol<br>Intravenous ketorolac prior to ERCP | Drug: Ketorolac<br>* Intravenous ketorolac<br>* Other names: Toradol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events |  | 5 days after ERCP procedure |