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

University of California San Francisco (UCSF)

Status and phase: Withdrawn; Phase 4

Conditions: Pancreatitis

Treatments: Drug: Placebo; Drug: Ketorolac

Study type: Interventional

Funder types: Other

Identifiers

NCT02465138

15-16365

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Normal Saline will be administered prior to procedure.

Treatment:

Drug: Placebo

Toradol

Active Comparator group

Description:

Intravenous ketorolac prior to ERCP

Treatment:

Drug: Ketorolac