Status:
UNKNOWN
Ketorolac in Acute Pancreatitis
Lead Sponsor:
University of Cincinnati
Conditions:
Acute Pancreatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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.
Detailed 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...
Eligibility Criteria
Inclusion
- 18 years old
- opioid order for pain secondary to acute pancreatitis
- diagnosis of acute pancreatitis defined by the presence of two of the following three criteria: abdominal pain, lipase \> 3x upper limit of normal, and/or findings of AP on imaging
- a patient with acute-on-chronic pancreatitis that does not exhibit elevated lipase levels 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 to ensure 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 negative pregnancy test
Exclusion
- history of chronic heart failure
- history of acute coronary syndrome (ST-elevation myocardial infarction (STEMI) or non-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
Key Trial Info
Start Date :
February 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04282200
Start Date
February 24 2020
End Date
December 1 2022
Last Update
December 8 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45219