Ketorolac in Acute Pancreatitis | NCT04282200

Studies
Ketorolac in Acute Pancreatitis

NCT04282200

Sponsor

University of Cincinnati

Status

Unknown status

Last Update Posted

Dec 8, 2020Actual

Enrollment

60Estimated

Phase

Phase 4

Conditions

Acute Pancreatitis

Interventions

Ketorolac

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 24, 2020Actual

Primary Completion Date

Dec 2021Estimated

Completion Date

Dec 2022Estimated

First Submitted Date

Feb 18, 2020

First Submission Date that Met QC Criteria

Feb 21, 2020

First Posted Date

Feb 24, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2020

Last Update Posted Date

Dec 8, 2020Actual

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Ketorolac	Drug	intravenous ketorolac 30 mg every 6 hours	Ketorolac

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Opioid use during study enrollment	oral morphine equivalents (OME)	day 1 to day 5 of study

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases

ID	Term
D007213	Indomethacin
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring