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

• ClinicalTrials.gov Identifier: NCT01901393
• Recruitment Status: Completed
• First Posted: July 17, 2013
• Results First Posted: February 15, 2016
• Last Update Posted: March 14, 2016
• Sponsor: Cumberland Pharmaceuticals
• Information provided by (Responsible Party): Cumberland Pharmaceuticals

Study Description

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)

Condition or disease	Intervention/treatment	Phase
Pain	Drug: IV ibuprofen; Drug: Ketorolac	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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
• Study Start Date: July 2013
• Actual Primary Completion Date: August 2014
• Actual Study Completion Date: August 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: IV ibuprofen; 800mg ibuprofen	Drug: IV ibuprofen; Other Name: Caldolor
Active Comparator: ketorolac; 30mg ketorolac	Drug: Ketorolac; Other Name: Ketorolac Tromethamine

Outcome Measures

Primary Outcome Measures :

1. Efficacy of Pain Relief (Pain Intensity at Rest) [ Time Frame: First possible time post-surgery, an expected average of 6 hours ]
   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).
2. Efficacy of Pain Relief (Pain Intensity With Movement) [ Time Frame: First possible time post-surgery, an expected average of 6 hours ]
   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).

Secondary Outcome Measures :

1. Rescue Medication Use in Post-operative Period [ Time Frame: Post-operative period until discharge, an expected average of 6 hours ]
   Amount of rescue medication (in milligrams) will be measured
2. Time to First Use of Rescue Med Will be Measured [ Time Frame: Post-operative period until discharge, an expected average of 6 hours ]
   Time to first rescue medication (in hours) in the postoperative period through discharge.
3. Patient Satisfaction [ Time Frame: Post-operative period until discharge, an expected average of 6 hours ]
   Measured using 2 question, 4 point scale.
4. Incidence of Serious Adverse Events [ Time Frame: Post-operative period until discharge, an expected average of 6 hours ]
   Number of subjects experiencing treatment-emergent serious adverse events

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

United States, Florida

Shrock Orthopedic Research

Fort Lauderdale, Florida, United States, 33316

United States, Illinois

Rush University Medical Center

Chicago, Illinois, United States, 60612

United States, Mississippi

North Mississippi Sports Medicine & Orthopaedic Clinic

Tupelo, Mississippi, United States, 38801

United States, Ohio

The Ohio State University Vexner Medical Center

Columbus, Ohio, United States, 43210

Sponsors and Collaborators

Cumberland Pharmaceuticals

Investigators

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

More Information

• Responsible Party: Cumberland Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT01901393
• Other Study ID Numbers: CPI-CL-020
• First Posted: July 17, 2013
• Results First Posted: February 15, 2016
• Last Update Posted: March 14, 2016
• Last Verified: February 2016

Keywords provided by Cumberland Pharmaceuticals:

Post Operative Pain,; Pail relief

Additional relevant MeSH terms:

Ibuprofen; Ketorolac; Ketorolac Tromethamine; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action