Ketorolac in Acute Pancreatitis

NCT04282200 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: 2019-0283
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pancreatitis

Outcome Measures

Primary Outcomes (1)

• Opioid use during study enrollment

  oral morphine equivalents (OME)

  day 1 to day 5 of study

Secondary Outcomes (2)

• Day-to-day oral morphine equivalents

  day 1 to day 5 of study

• Duration of intravenous opioid use

  During hospital admission

Study Arms (2)

Standard of Care

NO INTERVENTION

Patients receiving standard of care pain management including opioids.

Ketorolac

ACTIVE COMPARATOR

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

Drug: Ketorolac

Interventions

Ketorolac DRUG

intravenous ketorolac 30 mg every 6 hours

Ketorolac

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (1)

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

Location

MeSH Terms

Conditions

Pancreatitis

Interventions

Ketorolac

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Anthony J Gentene, PharmD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Pharmacy Specialist

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: February 24, 2020
• Study Start: February 24, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: December 8, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)