Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2020-02-24
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Standard of Care
Patients receiving standard of care pain management including opioids.
No interventions assigned to this group
Ketorolac
Patients will receive standard of care pain management plus intravenous ketorolac.
Ketorolac
intravenous ketorolac 30 mg every 6 hours
Interventions
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Ketorolac
intravenous ketorolac 30 mg every 6 hours
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
Yes
Sponsors
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University of Cincinnati
OTHER
Responsible Party
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Anthony Gentene
Clinical Pharmacy Specialist
Principal Investigators
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Anthony J Gentene, PharmD
Role: PRINCIPAL_INVESTIGATOR
University of Cincinnati
Locations
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University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Countries
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Other Identifiers
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2019-0283
Identifier Type: -
Identifier Source: org_study_id