Ketorolac in Acute Pancreatitis

• Status: Enrolling by invitation
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Cincinnati
• Treatments: Ketorolac; Ketorolac Tromethamine

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