Ketorolac in Acute Pancreatitis

University of Cincinnati

Status and phase: Unknown; Phase 4

Conditions: Acute Pancreatitis

Treatments: Drug: Ketorolac

Study type: Interventional

Funder types: Other

Identifiers

NCT04282200

2019-0283

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Standard of Care

No Intervention group

Description:

Patients receiving standard of care pain management including opioids.

Ketorolac

Active Comparator group

Description:

Patients will receive standard of care pain management plus intravenous ketorolac.

Treatment:

Drug: Ketorolac