Treatment of Acute Pancreatitis With Ketorolac

Study Overview
=================
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.

Official Title
-----------------
Treatment of Acute Pancreatitis With Ketorolac

Conditions
-----------------
Acute Pancreatitis

Intervention / Treatment
-----------------
* Drug: Ketorolac


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketorolac<br>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 | Drug: Ketorolac<br>* Ketorolac, 10 mg, 3 times daily from time of enrollment until 72 hours from enrollment. For up to a maximum of 9 doses.<br>* Other names: Toradol;|
| No Intervention: Control<br>The standard medical treatment | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in C-Reactive Protein (CRP) | baseline to Day 5 | baseline to Day 5 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inflammation