A Randomized Controlled Trial of IV Ketorolac to Prevent Post-ERCP Pancreatitis
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 1/16/2019 |
| Start Date: | July 2019 |
| End Date: | December 2019 |
| Contact: | John P Cello, MD |
| Email: | john.cello@ucsf.edu |
| Phone: | 415-206-4767 |
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.
Determine if IV ketorolac provides improved post-procedure analgesia.
Determine if systemic mediators of inflammation are reduced in patients receiving IV
ketorolac following ERCP.
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.
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.
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
We found this trial at
2
sites
1001 Potrero Ave
San Francisco, California 94110
San Francisco, California 94110
(415) 206-8000
Principal Investigator: Anupam Aditi, MD
San Francisco General Hospital San Francisco General Hospital and Trauma Center (SFGH) is an essential...
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