Ketorolac in Acute Pancreatitis

Sponsor

University of Cincinnati (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04282200

Collaborator

(none)

Enrollment

Location

Arms

33.2

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Pancreatitis	Drug: Ketorolac	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Feb 24, 2020

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Opioid use during study enrollment [day 1 to day 5 of study]
oral morphine equivalents (OME)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Cincinnati Medical Center	Cincinnati	Ohio	United States	45219

Sponsors and Collaborators

University of Cincinnati

Investigators

Principal Investigator: Anthony J Gentene, PharmD, University of Cincinnati

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Anthony Gentene, Clinical Pharmacy Specialist, University of Cincinnati

ClinicalTrials.gov Identifier:

NCT04282200

Other Study ID Numbers:

2019-0283

First Posted:

Feb 24, 2020

Last Update Posted:

Dec 8, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Pancreatitis

Ketorolac

Study Results

No Results Posted as of Dec 8, 2020