Efficacy of Intravenous Ibuprofen Compared to Intravenous Ketorolac for Pain Control Following Arthroscopic Knee Surgery

NCT01901393 | Completed Phase 4 Results

• 1 other identifier: CPI-CL-020
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to assess the efficacy of intravenous ibuprofen compared to ketorolac for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS)

Conditions

Pain

Keywords

Post Operative Pain,; Pail relief

Outcome Measures

Primary Outcomes (2)

• Efficacy of Pain Relief (Pain Intensity at Rest)

  Pain assessed using VAS (Visual Analog Scale, VAS). The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the "No Pain" anchor and the subject's mark. The score would be between 0 (No Pain) and 100 (Worst Possible Pain).

  First possible time post-surgery, an expected average of 6 hours

• Efficacy of Pain Relief (Pain Intensity With Movement)

  Pain assessed using VAS (Visual Analog Scale, VAS). The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the "No Pain" anchor and the subject's mark. The score would be between 0 (No Pain) and 100 (Worst Possible Pain).

  First possible time post-surgery, an expected average of 6 hours

Secondary Outcomes (4)

• Rescue Medication Use in Post-operative Period

  Post-operative period until discharge, an expected average of 6 hours

• Time to First Use of Rescue Med Will be Measured

  Post-operative period until discharge, an expected average of 6 hours

• Patient Satisfaction

  Post-operative period until discharge, an expected average of 6 hours

• Incidence of Serious Adverse Events

  Post-operative period until discharge, an expected average of 6 hours

Study Arms (2)

IV ibuprofen

EXPERIMENTAL

800mg ibuprofen

Drug: IV ibuprofen

ketorolac

ACTIVE COMPARATOR

30mg ketorolac

Drug: Ketorolac

Interventions

IV ibuprofen DRUG

Also known as: Caldolor

IV ibuprofen

Ketorolac DRUG

Also known as: Ketorolac Tromethamine

ketorolac

Eligibility Criteria

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

You may qualify if:

• Patients scheduled for knee arthroscopy

You may not qualify if:

• Inadequate IV access.
• History of allergy or hypersensitivity to any component of ibuprofen, ketorolac, aspirin (or aspirin related products), non-steroidal anti-inflammatory drugs (NSAIDs), opioids or cyclooxygenase-2 (COX-2) inhibitors.
• Less than 18 years of age.
• Use of analgesics less than 8 hours prior to surgery.
• Patients with active, clinically significant anemia.
• History or evidence of asthma or heart failure.
• Pregnant.
• Recent history of chronic opioid use.
• Concomitant use of probenecid.
• Inability to understand the requirements of the study, be willing to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board \[IRB\]), and agree to abide by the study restrictions and to return for the required assessments.
• Refusal to provide written authorization for use and disclosure of protected health information.

Sponsors & Collaborators

• Cumberland Pharmaceuticals: lead

Study Sites (4)

Shrock Orthopedic Research

Fort Lauderdale, Florida, 33316, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

North Mississippi Sports Medicine & Orthopaedic Clinic

Tupelo, Mississippi, 38801, United States

Location

The Ohio State University Vexner Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Pain; Pain, Postoperative

Interventions

Ibuprofen; Ketorolac; Ketorolac Tromethamine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Amy Rock, PhD
• Organization: Cumberland Pharmaceutical Inc.

arock@cumberlandpharma.com

615-255-0068

Study Officials

• Arthur P Wheeler, MD

  Cumberland Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2013
• First Posted: July 17, 2013
• Study Start: July 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: March 14, 2016
• Results First Posted: February 15, 2016

Record last verified: 2016-02

Locations

US (4)