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Summary

for people ages 18–85 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

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.

Details

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.

Keywords

Pancreatitis Ketorolac Ketorolac Tromethamine

Eligibility

You can join if…

Open to people ages 18–85

  • All patients presenting to SFGH for ERCP
  • Age 18-85
  • Do not meet

You CAN'T join if...

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

Locations

  • San Francisco General Hospital not yet accepting patients
    San Francisco, California, 94117, United States
  • UCSF/San Francisco General Hospital
    San Francisco, California, 94132/94110, United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT02465138
Phase
Phase 4
Lead Scientist
John P Cello
Study Type
Interventional
Last Updated
January 2016
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