Treatment of Acute Pancreatitis With Ketorolac

Ilam University of Medical Sciences

Status and phase: Terminated; Phase 4

Conditions: Acute Pancreatitis

Treatments: Drug: Ketorolac

Study type: Interventional

Funder types: Other

Identifiers

NCT02885441

22/52/1663

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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56 participants in 2 patient groups

Ketorolac

Experimental group

Description:

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

Treatment:

Drug: Ketorolac

Control

No Intervention group

Description:

The standard medical treatment