Treatment of Acute Pancreatitis With Ketorolac
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|ClinicalTrials.gov Identifier: NCT02885441|
Recruitment Status : Terminated
First Posted : August 31, 2016
Last Update Posted : February 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Pancreatitis||Drug: Ketorolac||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Treatment of Acute Pancreatitis With Ketorolac|
|Actual Study Start Date :||September 2016|
|Actual Primary Completion Date :||February 1, 2019|
|Actual Study Completion Date :||February 1, 2019|
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, 10 mg, 3 times daily from time of enrollment until 72 hours from enrollment. For up to a maximum of 9 doses.
Other Name: Toradol
No Intervention: Control
The standard medical treatment
- Change in C-Reactive Protein (CRP) [ Time Frame: baseline, Day 1, Day 3 ]
- Number Of Subjects With New Onset Organ Failure During Hospitalization [ Time Frame: 30 days or until dismissal date whichever occurs earlier ]
- Number Of Subjects With New Onset Pancreatic Necrosis During Hospitalization [ Time Frame: 30 days or until dismissal date whichever occurs earlier ]
- Duration of hospitalization [ Time Frame: 30 days or until dismissal date whichever occurs earlier ]
- Mortality [ Time Frame: 30 days or until dismissal date whichever occurs earlier ]
- Time of beginning and tolerance to nutrition [ Time Frame: 30 days or until dismissal date whichever occurs earlier ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02885441
|Iran, Islamic Republic of|
|Ilam University of Medical Scienvc|
|Ilam, Iran, Islamic Republic of, 6939177143|
|Study Chair:||Shaahin Shahbazi, MD||Head of Faculty of Medicine|