Treatment of Acute Pancreatitis With Ketorolac

Phase 4

Terminated

• Conditions: Acute Pancreatitis
• Interventions: Drug: Ketorolac

• Registration Number: NCT02885441
• Lead Sponsor: Ilam University of Medical Sciences

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.

Study Timeline

• Study First Submitted: 2016-08-23
• Study First Submitted QC: 2016-08-30
• Study First Posted: 2016-08-31
• Study Start: 2016-09
• Status Verified: 2019-01
• Primary Completion: 2019-02-01
• Study Completion: 2019-02-01
• Last Update Submitted: 2019-05-13
• Last Update Posted: 2019-05-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketorolac	Ketorolac	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

Primary Outcome Measures

Name	Time	Method
Change in C-Reactive Protein (CRP)	baseline to Day 5	baseline to Day 5

Secondary Outcome Measures

Name	Time	Method
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
Mortality	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
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

Trial Locations

Locations (1)

Ilam University of Medical Scienvc; 🇮🇷 Ilam, Iran, Islamic Republic of