Acute Pancreatitis
Conditions
Keywords
Inflammation
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.
Interventions
DRUGKetorolac
Ketorolac, 10 mg, 3 times daily from time of enrollment until 72 hours from enrollment. For up to a maximum of 9 doses.
Sponsors
Ilam University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Predicted Severe Acute Pancreatitis 2. Enrollment within 72 hours of diagnosis 3. Obtaining informed consent 4. Age \>18 years
Exclusion criteria
1. Heart disease, Hypertension 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in C-Reactive Protein (CRP) | baseline to Day 5 | baseline to Day 5 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Iran
Outcome results
None listed