Ketorolac in Acute Pancreatitis
Primary Purpose
Acute Pancreatitis
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ketorolac
Sponsored by
About this trial
This is an interventional supportive care trial for Acute Pancreatitis
Eligibility Criteria
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 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 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
Sites / Locations
- University of Cincinnati Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Standard of Care
Ketorolac
Arm Description
Patients receiving standard of care pain management including opioids.
Patients will receive standard of care pain management plus intravenous ketorolac.
Outcomes
Primary Outcome Measures
Opioid use during study enrollment
oral morphine equivalents (OME)
Secondary Outcome Measures
Day-to-day oral morphine equivalents
Compare opioid use in each day of study
Duration of intravenous opioid use
compare duration of need for IV opioids and transition to oral opioids
Full Information
NCT ID
NCT04282200
First Posted
February 18, 2020
Last Updated
December 4, 2020
Sponsor
University of Cincinnati
1. Study Identification
Unique Protocol Identification Number
NCT04282200
Brief Title
Ketorolac in Acute Pancreatitis
Official Title
The Use of Intravenous Ketorolac in a Multimodal Approach to Pain Management in Acute Pancreatitis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 24, 2020 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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 standard of care or standard of care plus intravenous ketorolac. Patients will be enrolled between hour 24 and 48 of hospitalization.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pancreatitis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Patients receiving standard of care pain management including opioids.
Arm Title
Ketorolac
Arm Type
Active Comparator
Arm Description
Patients will receive standard of care pain management plus intravenous ketorolac.
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Intervention Description
intravenous ketorolac 30 mg every 6 hours
Primary Outcome Measure Information:
Title
Opioid use during study enrollment
Description
oral morphine equivalents (OME)
Time Frame
day 1 to day 5 of study
Secondary Outcome Measure Information:
Title
Day-to-day oral morphine equivalents
Description
Compare opioid use in each day of study
Time Frame
day 1 to day 5 of study
Title
Duration of intravenous opioid use
Description
compare duration of need for IV opioids and transition to oral opioids
Time Frame
During hospital admission
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony J Gentene, PharmD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Ketorolac in Acute Pancreatitis
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