Ketorolac in Acute Pancreatitis

Last updated: December 4, 2020
Sponsor: University of Cincinnati
Overall Status: Active - Enrolling

Phase

4

Condition

Pancreatitis

Treatment

N/A

Clinical Study ID

NCT04282200
2019-0283
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This study will compare pain management strategies for patients hospitalized with acute pancreatitis. Standard of care pain management will be compared to standard of care plus intravenous ketorolac.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 years old
  • opioid order for pain secondary to acute pancreatitis
  • diagnosis of acute pancreatitis defined by the presence of two of the following threecriteria: abdominal pain, lipase > 3x upper limit of normal, and/or findings of AP onimaging
  • a patient with acute-on-chronic pancreatitis that does not exhibit elevated lipaselevels is eligible for inclusion if the patient has the other two criteria
  • received at least 3 L of IV crystalloid fluid within first 24 hours of admission toensure patients have received initial volume expansion
  • hemodynamically stable represented by a mean arterial blood pressure (MAP) of ≥65 mmHg
  • female patients not documented in chart as post-menopause must have a negativepregnancy test

Exclusion

Exclusion Criteria:

  • history of chronic heart failure
  • history of acute coronary syndrome (ST-elevation myocardial infarction (STEMI) ornon-ST elevation myocardial infarction (NSTEMI)) within last 6 months
  • history of ischemic or hemorrhagic stroke within last 6 months
  • history of upper gastrointestinal bleed (GI) within last 6 months
  • history of inflammatory bowel disease
  • history of cirrhosis
  • any overt, active bleeding requiring blood transfusion
  • considered to be high bleed risk (platelet < 50,000/mcL)
  • pregnant or breastfeeding
  • prisoners
  • cognitively impaired patients: not alert and oriented to person, place, and time (patient must be able to consent)
  • allergy to NSAIDs, ketorolac, or aspirin
  • admission to an intensive care unit
  • evidence of infected pancreatitis (i.e. abscess) on imaging studies
  • acute kidney injury or chronic kidney disease with CrCl<30

Study Design

Total Participants: 60
Study Start date:
February 24, 2020
Estimated Completion Date:
December 31, 2022

Study Description

Patients hospitalized for acute pancreatitis and admitted to an internal medicine team will be eligible for study. Patients enrolled will be blindly randomized to receive open-label pain management of standard of care or standard of care plus intravenous ketorolac. Patients will be enrolled between hour 24 and 48 of hospitalization.

Connect with a study center

  • University of Cincinnati Medical Center

    Cincinnati, Ohio 45219
    United States

    Site Not Available

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