Ketorolac in Acute Pancreatitis

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

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.

Study Overview

• Status: Unknown
• Conditions: Acute Pancreatitis
• Intervention / Treatment: Drug: 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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Cincinnati
• Investigators: Principal Investigator: Anthony J Gentene, PharmD, University of Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2020
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: February 18, 2020
• First Submitted That Met QC Criteria: February 21, 2020
• First Posted (Actual): February 24, 2020

Study Record Updates

• Last Update Posted (Actual): December 8, 2020
• Last Update Submitted That Met QC Criteria: December 4, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ketorolac
• Other Study ID Numbers: 2019-0283

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes