Clinical trial NCT02885441: Treatment of Acute Pancreatitis With Ketorolac
Official title: Treatment of Acute Pancreatitis With Ketorolac
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Acute Pancreatitis
Keywords: Inflammation
Lead sponsor: Ilam University of Medical Sciences
Sponsor class: OTHER
First posted: 2016-08-31
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in C-Reactive Protein (CRP)
timeFrame: baseline to Day 5
Secondary outcomes:
measure: Number Of Subjects With New Onset Organ Failure During Hospitalization
timeFrame: 30 days or until dismissal date whichever occurs earlier
measure: Number Of Subjects With New Onset Pancreatic Necrosis During Hospitalization
timeFrame: 30 days or until dismissal date whichever occurs earlier
measure: Duration of hospitalization
timeFrame: 30 days or until dismissal date whichever occurs earlier
measure: Mortality
timeFrame: 30 days or until dismissal date whichever occurs earlier
measure: Time of beginning and tolerance to nutrition
timeFrame: 30 days or until dismissal date whichever occurs earlier
Other outcomes:
Locations:
city: Ilam
country: Iran, Islamic Republic of
facility: Ilam University of Medical Scienvc
Study officials:
affiliation: Head of Faculty of Medicine
name: Shaahin Shahbazi, MD
role: STUDY_CHAIR
References: