Treatment of Acute Pancreatitis With Ketorolac

Acute Pancreatitis Clinical Trial

Official title:

Treatment of Acute Pancreatitis With Ketorolac

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02885441
• Other study ID #: 22/52/1663
• Status: Terminated
• Phase: Phase 4
• Start date: September 2016
• Est. completion date: February 1, 2019

Study information

• Verified date: January 2019
• Source: Ilam University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 56
• Est. completion date: February 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pancreatitis
• Pancreatitis

Intervention

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Ilam University of Medical Scienvc	Ilam

Sponsors (1)

Lead Sponsor	Collaborator
Ilam University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in C-Reactive Protein (CRP)	baseline to Day 5	baseline to Day 5
Secondary	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
Secondary	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
Secondary	Duration of hospitalization	30 days or until dismissal date whichever occurs earlier	30 days or until dismissal date whichever occurs earlier
Secondary	Mortality	30 days or until dismissal date whichever occurs earlier	30 days or until dismissal date whichever occurs earlier
Secondary	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