Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
56 participants
INTERVENTIONAL
2016-09-30
2019-02-01
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Ketorolac
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
Ketorolac
Ketorolac, 10 mg, 3 times daily from time of enrollment until 72 hours from enrollment. For up to a maximum of 9 doses.
Control
The standard medical treatment
No interventions assigned to this group
Interventions
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Ketorolac
Ketorolac, 10 mg, 3 times daily from time of enrollment until 72 hours from enrollment. For up to a maximum of 9 doses.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Enrollment within 72 hours of diagnosis
3. Obtaining informed consent
4. Age \>18 years
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Ilam University of Medical Sciences
OTHER
Responsible Party
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Zahra Vahdat Shariatpanahi
Associated Professor
Principal Investigators
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Shaahin Shahbazi, MD
Role: STUDY_CHAIR
Head of Faculty of Medicine
Locations
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Ilam University of Medical Scienvc
Īlām, , Iran
Countries
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Other Identifiers
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22/52/1663
Identifier Type: -
Identifier Source: org_study_id
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