Treatment of Acute Pancreatitis With Ketorolac

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.

Study Overview

• Status: Terminated
• Conditions: Acute Pancreatitis
• Intervention / Treatment: Drug: Ketorolac

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 Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 4

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Ilam, Iran, Islamic Republic of, 6939177143
    • Ilam University of Medical Scienvc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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.; Other Names: Toradol
No Intervention: Control; The standard medical treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in C-Reactive Protein (CRP)	baseline to Day 5	baseline to Day 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Duration of 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
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

Collaborators and Investigators

• Sponsor: Ilam University of Medical Sciences
• Investigators: Study Chair: Shaahin Shahbazi, MD, Head of faculty of medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: August 23, 2016
• First Submitted That Met QC Criteria: August 30, 2016
• First Posted (Estimate): August 31, 2016

Study Record Updates

• Last Update Posted (Actual): May 15, 2019
• Last Update Submitted That Met QC Criteria: May 13, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Inflammation
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ketorolac
• Other Study ID Numbers: 22/52/1663

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No