Clinical trial NCT04282200: Ketorolac in Acute Pancreatitis
Official title: The Use of Intravenous Ketorolac in a Multimodal Approach to Pain Management in Acute Pancreatitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Pancreatitis
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2020-02-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Opioid use during study enrollment
timeFrame: day 1 to day 5 of study
Secondary outcomes:
measure: Day-to-day oral morphine equivalents
timeFrame: day 1 to day 5 of study
measure: Duration of intravenous opioid use
timeFrame: During hospital admission
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Anthony J Gentene, PharmD
role: PRINCIPAL_INVESTIGATOR
References: