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
About this trial
This is an interventional treatment trial for Acute Pancreatitis focused on measuring Inflammation
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
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
NCT ID
NCT02885441
First Posted
August 23, 2016
Last Updated
May 13, 2019
Sponsor
Ilam University of Medical Sciences
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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