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Trial record 25 of 463 for:    KETOROLAC

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

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ClinicalTrials.gov Identifier: NCT02465138
Recruitment Status : Not yet recruiting
First Posted : June 8, 2015
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
John P. Cello, M.D., 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.


Condition or disease Intervention/treatment Phase
Pancreatitis Drug: Ketorolac Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of IV Ketorolac to Prevent Post-ERCP Pancreatitis
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Arm Intervention/treatment
Placebo Comparator: Placebo
Normal Saline will be administered prior to procedure.
Drug: Placebo
Intravenous saline

Active Comparator: Toradol
Intravenous ketorolac prior to ERCP
Drug: Ketorolac
Intravenous ketorolac
Other Name: Toradol




Primary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: 5 days after ERCP procedure ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02465138


Contacts
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Contact: John P Cello, MD 415-206-4767 john.cello@ucsf.edu
Contact: Stanley J Rogers, MD 415-476-0762 stan.rogers@ucsf.edu

Locations
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United States, California
San Francisco General Hospital Not yet recruiting
San Francisco, California, United States, 94117
Contact: Alex Rodas       arodas@medsfgh.ucsf.edu   
Principal Investigator: Anupam Aditi, MD         
Principal Investigator: John P Cello, MD         
Principal Investigator: Stanley J Rogers, MD         
UCSF/San Francisco General Hospital
San Francisco, California, United States, 94132/94110
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: John P Cello, MD University of California, San Francisco

Publications of Results:

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Responsible Party: John P. Cello, M.D., Professor of Medicine and Surgery, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02465138     History of Changes
Other Study ID Numbers: 15-16365
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Ketorolac
Ketorolac Tromethamine
Pancreatitis
Pancreatic Diseases
Digestive System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action