A Randomized Controlled Trial of IV Ketorolac to Prevent Post-ERCP Pancreatitis
- Registration Number
- NCT02465138
- Lead Sponsor
- University of California, San Francisco
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- All patients presenting to SFGH for ERCP
- Age 18-85
- Do not meet 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Normal Saline will be administered prior to procedure. Toradol Ketorolac Intravenous ketorolac prior to ERCP
- Primary Outcome Measures
Name Time Method Number of participants with adverse events 5 days after ERCP procedure
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
UCSF/San Francisco General Hospital
🇺🇸San Francisco, California, United States
San Francisco General Hospital
🇺🇸San Francisco, California, United States