Ketorolac in Acute Pancreatitis

Acute Pancreatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04282200
• Other study ID #: 2019-0283
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: February 24, 2020
• Est. completion date: December 2022

Study information

• Verified date: December 2020
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: December 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pancreatitis
• Pancreatitis

Intervention

Drug:
• Ketorolac
intravenous ketorolac 30 mg every 6 hours

Locations

Country	Name	City	State
United States	University of Cincinnati Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid use during study enrollment	oral morphine equivalents (OME)	day 1 to day 5 of study
Secondary	Day-to-day oral morphine equivalents	Compare opioid use in each day of study	day 1 to day 5 of study
Secondary	Duration of intravenous opioid use	compare duration of need for IV opioids and transition to oral opioids	During hospital admission