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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.
Patients with acute pancreatitis will be randomly assigned in either study group or control group.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketorolac | Experimental | 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 |
|
| Control | No Intervention | The standard medical treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketorolac | Drug | Ketorolac, 10 mg, 3 times daily from time of enrollment until 72 hours from enrollment. For up to a maximum of 9 doses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in C-Reactive Protein (CRP) | baseline to Day 5 | baseline to Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Number Of Subjects With New Onset Organ Failure During Hospitalization | 30 days or until dismissal date whichever occurs earlier | 30 days or until dismissal date whichever occurs earlier |
| Number Of Subjects With New Onset Pancreatic Necrosis During Hospitalization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shaahin Shahbazi, MD | Head of Faculty of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ilam University of Medical Scienvc | Īlām | 6939177143 | Iran |
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| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D020910 | Ketorolac |
| D020911 | Ketorolac Tromethamine |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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30 days or until dismissal date whichever occurs earlier |
| 30 days or until dismissal date whichever occurs earlier |
| Duration of hospitalization | 30 days or until dismissal date whichever occurs earlier | 30 days or until dismissal date whichever occurs earlier |
| Mortality | 30 days or until dismissal date whichever occurs earlier | 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 | 30 days or until dismissal date whichever occurs earlier |
| D006571 | Heterocyclic Compounds |