Clinical trial NCT02465138: A Randomized Controlled Trial of IV Ketorolac to Prevent Post-ERCP Pancreatitis
Official title: A Randomized Controlled Trial of IV Ketorolac to Prevent Post-ERCP Pancreatitis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Pancreatitis
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2015-06-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: 5 days after ERCP procedure
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco General Hospital
state: California
city: San Francisco
country: United States
facility: UCSF/San Francisco General Hospital
state: California
Study officials:
affiliation: University of California, San Francisco
name: John P Cello, MD
role: PRINCIPAL_INVESTIGATOR
References:
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