Ketorolac in Acute Pancreatitis

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Use of Intravenous Ketorolac in a Multimodal Approach to Pain Management in Acute Pancreatitis

Conditions
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Acute Pancreatitis

Intervention / Treatment
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* Drug: Ketorolac


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care<br>Patients receiving standard of care pain management including opioids. | |
| Active Comparator: Ketorolac<br>Patients will receive standard of care pain management plus intravenous ketorolac. | Drug: Ketorolac<br>* intravenous ketorolac 30 mg every 6 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid use during study enrollment | oral morphine equivalents (OME) | day 1 to day 5 of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Day-to-day oral morphine equivalents | Compare opioid use in each day of study | day 1 to day 5 of study | 
| Duration of intravenous opioid use | compare duration of need for IV opioids and transition to oral opioids | During hospital admission |