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

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

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)

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: IV ibuprofen; Drug: Ketorolac

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Fort Lauderdale, Florida, United States, 33316
      • Shrock Orthopedic Research
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • Mississippi
    • Tupelo, Mississippi, United States, 38801
      • North Mississippi Sports Medicine & Orthopaedic Clinic
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Vexner Medical Center

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:

• 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 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: IV ibuprofen; 800mg ibuprofen	Drug: IV ibuprofen; Other Names: Caldolor
Active Comparator: ketorolac; 30mg ketorolac	Drug: Ketorolac; Other Names: Ketorolac Tromethamine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Patient Satisfaction	Measured using 2 question, 4 point scale.	Post-operative period until discharge, an expected average of 6 hours
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

Collaborators and Investigators

• Sponsor: Cumberland Pharmaceuticals
• Investigators: Study Director: Arthur P Wheeler, MD, Cumberland Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: July 12, 2013
• First Submitted That Met QC Criteria: July 15, 2013
• First Posted (Estimate): July 17, 2013

Study Record Updates

• Last Update Posted (Estimate): March 14, 2016
• Last Update Submitted That Met QC Criteria: February 12, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Post Operative Pain,; Pail relief
• Additional Relevant MeSH Terms: 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; Ibuprofen; Ketorolac Tromethamine
• Other Study ID Numbers: CPI-CL-020