Treatment of Acute Pancreatitis With Ketorolac

Phase 4TerminatedNCT02885441

Ilam University of Medical Sciences56 enrolled

Overview

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. * 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Acute Pancreatitis

Interventions

KetorolacDRUG

Ketorolac, 10 mg, 3 times daily from time of enrollment until 72 hours from enrollment. For up to a maximum of 9 doses.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Ilam University of Medical Scienvc

Īlām, Iran

Outcomes

Primary Outcomes

Change in C-Reactive Protein (CRP)

baseline to Day 5

Time frame: baseline to Day 5