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

Pain Clinical Trial

Official title:

A Multicenter, Prospective, Randomized, Double-blind Study to Determine the Efficacy of Intravenous Ibuprofen Compared to Intravenous Ketorolac for Pain Control Following Arthroscopic Knee Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01901393
• Other study ID #: CPI-CL-020
• Status: Completed
• Phase: Phase 4
• First received: July 12, 2013
• Last updated: February 12, 2016
• Start date: July 2013
• Est. completion date: August 2014

Study information

• Verified date: February 2016
• Source: Cumberland Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients scheduled for knee arthroscopy

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• IV ibuprofen

• Ketorolac

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois
United States	The Ohio State University Vexner Medical Center	Columbus	Ohio
United States	Shrock Orthopedic Research	Fort Lauderdale	Florida
United States	North Mississippi Sports Medicine & Orthopaedic Clinic	Tupelo	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
Cumberland Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Rescue Medication Use in Post-operative Period	Amount of rescue medication (in milligrams) will be measured	Post-operative period until discharge, an expected average of 6 hours	No
Secondary	Time to First Use of Rescue Med Will be Measured	Time to first rescue medication (in hours) in the postoperative period through discharge.	Post-operative period until discharge, an expected average of 6 hours	No
Secondary	Patient Satisfaction	Measured using 2 question, 4 point scale.	Post-operative period until discharge, an expected average of 6 hours	No
Secondary	Incidence of Serious Adverse Events	Number of subjects experiencing treatment-emergent serious adverse events	Post-operative period until discharge, an expected average of 6 hours	Yes