Acute Pancreatitis
Conditions
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.
Interventions
DRUGKetorolac
intravenous ketorolac 30 mg every 6 hours
Sponsors
University of Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid use during study enrollment | day 1 to day 5 of study | oral morphine equivalents (OME) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Day-to-day oral morphine equivalents | day 1 to day 5 of study | Compare opioid use in each day of study |
| Duration of intravenous opioid use | During hospital admission | compare duration of need for IV opioids and transition to oral opioids |
Countries
United States
Outcome results
None listed