Ketorolac in Acute Pancreatitis

Phase 4

• Conditions: Acute Pancreatitis
• Interventions: Drug: Ketorolac

• Registration Number: NCT04282200
• Lead Sponsor: University of Cincinnati

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.

Study Timeline

• Study First Submitted: 2020-02-18
• Study First Submitted QC: 2020-02-21
• Study Start: 2020-02-24
• Study First Posted: 2020-02-24
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-04
• Last Update Posted: 2020-12-08
• Primary Completion: 2021-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketorolac	Ketorolac	Patients will receive standard of care pain management plus intravenous ketorolac.

Primary Outcome Measures

Name	Time	Method
Opioid use during study enrollment	day 1 to day 5 of study	oral morphine equivalents (OME)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Cincinnati Medical Center; 🇺🇸 Cincinnati, Ohio, United States