Treatment of Acute Pancreatitis With Ketorolac

NCT02885441 | Terminated Phase 4

• 1 other identifier: 22/52/1663
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pancreatitis

Keywords

Inflammation

Outcome Measures

Primary Outcomes (1)

• Change in C-Reactive Protein (CRP)

  baseline to Day 5

  baseline to Day 5

Secondary Outcomes (5)

• Number Of Subjects With New Onset Organ Failure During Hospitalization

  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

• Duration of hospitalization

  30 days or until dismissal date whichever occurs earlier

• Mortality

  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

Study Arms (2)

Ketorolac

EXPERIMENTAL

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

Control

NO INTERVENTION

The standard medical treatment

Interventions

Ketorolac DRUG

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

Also known as: Toradol

Ketorolac

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Predicted Severe Acute Pancreatitis
• Enrollment within 72 hours of diagnosis
• Obtaining informed consent
• Age \>18 years

You may not qualify if:

• Heart disease, Hypertension
• Hemorrhagic diathesis, Incomplete hemostasis, High risk of bleeding
• Lactating women
• Pregnancy
• Advanced renal disease
• Hypersensitivity to ketorolac, aspirin, other NSAIDs
• Concurrent use with aspirin, other NSAIDs, probenecid, or pentoxifylline
• Active or history of peptic ulcer disease
• Recent or history of GI bleeding or perforation
• Inflammatory bowel disease
• Severe hepatic impairment or active hepatic disease

Sponsors & Collaborators

• Ilam University of Medical Sciences: lead

Study Sites (1)

Ilam University of Medical Scienvc

Īlām, 6939177143, Iran

Location

MeSH Terms

Conditions

Pancreatitis; Inflammation

Interventions

Ketorolac; Ketorolac Tromethamine

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Shaahin Shahbazi, MD

  Head of Faculty of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: August 23, 2016
• First Posted: August 31, 2016
• Study Start: September 1, 2016
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: May 15, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)