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Treatment of Acute Pancreatitis With Ketorolac

Primary Purpose

Acute Pancreatitis

Status
Terminated
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Ketorolac
Sponsored by
Ilam University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pancreatitis focused on measuring Inflammation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Predicted Severe Acute Pancreatitis
  2. Enrollment within 72 hours of diagnosis
  3. Obtaining informed consent
  4. Age >18 years

Exclusion Criteria:

  1. Heart disease, Hypertension
  2. Hemorrhagic diathesis, Incomplete hemostasis, High risk of bleeding
  3. Lactating women
  4. Pregnancy
  5. Advanced renal disease
  6. Hypersensitivity to ketorolac, aspirin, other NSAIDs
  7. Concurrent use with aspirin, other NSAIDs, probenecid, or pentoxifylline
  8. Active or history of peptic ulcer disease
  9. Recent or history of GI bleeding or perforation
  10. Inflammatory bowel disease
  11. Severe hepatic impairment or active hepatic disease

Sites / Locations

  • Ilam University of Medical Scienvc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Ketorolac

Control

Arm Description

Ketorolac,10 mg, 3 times daily from time of enrollment until 72 hours from enrollment for up to a maximum of 9 doses, along with the standard medical treatment

The standard medical treatment

Outcomes

Primary Outcome Measures

Change in C-Reactive Protein (CRP)
baseline to Day 5

Secondary Outcome Measures

Number Of Subjects With New Onset Organ Failure During Hospitalization
30 days or until dismissal date whichever occurs earlier
Number Of Subjects With New Onset Pancreatic Necrosis During Hospitalization
30 days or until dismissal date whichever occurs earlier
Duration of hospitalization
30 days or until dismissal date whichever occurs earlier
Mortality
30 days or until dismissal date whichever occurs earlier
Time of beginning and tolerance to nutrition
30 days or until dismissal date whichever occurs earlier

Full Information

First Posted
August 23, 2016
Last Updated
May 13, 2019
Sponsor
Ilam University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02885441
Brief Title
Treatment of Acute Pancreatitis With Ketorolac
Official Title
Treatment of Acute Pancreatitis With Ketorolac
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Terminated
Study Start Date
September 2016 (Actual)
Primary Completion Date
February 1, 2019 (Actual)
Study Completion Date
February 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ilam University of Medical Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Patients with acute pancreatitis will be randomly assigned in either study group to receive oral (injection) Ketorolac or the control group. In patients who cannot tolerate oral medications, ketorolac injection will be used.
Detailed Description
Patients with acute pancreatitis will be randomly assigned in either study group or control group. The study group will receive injection or oral Ketorolac. The control group will receive standard medical treatment. Ketorolac is administrated three times daily by mouth or injection starting from the time of admission for the first three days of hospitalization (72 hours). Hs-CRP will be measured in admission in addition to standard laboratory tests.It will be done every day for up to 5 days, after the administration of study drug or till the time of discharge whichever occurs earlier. Patients will follow up for organ failure involvement and duration of hospitalization. The study will continue to gather clinical follow up information up to four months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pancreatitis
Keywords
Inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketorolac
Arm Type
Experimental
Arm Description
Ketorolac,10 mg, 3 times daily from time of enrollment until 72 hours from enrollment for up to a maximum of 9 doses, along with the standard medical treatment
Arm Title
Control
Arm Type
No Intervention
Arm Description
The standard medical treatment
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Other Intervention Name(s)
Toradol
Intervention Description
Ketorolac, 10 mg, 3 times daily from time of enrollment until 72 hours from enrollment. For up to a maximum of 9 doses.
Primary Outcome Measure Information:
Title
Change in C-Reactive Protein (CRP)
Description
baseline to Day 5
Time Frame
baseline to Day 5
Secondary Outcome Measure Information:
Title
Number Of Subjects With New Onset Organ Failure During Hospitalization
Description
30 days or until dismissal date whichever occurs earlier
Time Frame
30 days or until dismissal date whichever occurs earlier
Title
Number Of Subjects With New Onset Pancreatic Necrosis During Hospitalization
Description
30 days or until dismissal date whichever occurs earlier
Time Frame
30 days or until dismissal date whichever occurs earlier
Title
Duration of hospitalization
Description
30 days or until dismissal date whichever occurs earlier
Time Frame
30 days or until dismissal date whichever occurs earlier
Title
Mortality
Description
30 days or until dismissal date whichever occurs earlier
Time Frame
30 days or until dismissal date whichever occurs earlier
Title
Time of beginning and tolerance to nutrition
Description
30 days or until dismissal date whichever occurs earlier
Time Frame
30 days or until dismissal date whichever occurs earlier

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Predicted Severe Acute Pancreatitis Enrollment within 72 hours of diagnosis Obtaining informed consent Age >18 years Exclusion Criteria: Heart disease, Hypertension Hemorrhagic diathesis, Incomplete hemostasis, High risk of bleeding Lactating women Pregnancy Advanced renal disease Hypersensitivity to ketorolac, aspirin, other NSAIDs Concurrent use with aspirin, other NSAIDs, probenecid, or pentoxifylline Active or history of peptic ulcer disease Recent or history of GI bleeding or perforation Inflammatory bowel disease Severe hepatic impairment or active hepatic disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaahin Shahbazi, MD
Organizational Affiliation
Head of Faculty of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Ilam University of Medical Scienvc
City
Ilam
ZIP/Postal Code
6939177143
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Treatment of Acute Pancreatitis With Ketorolac

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