Clinical trial NCT01901393: Efficacy of Intravenous Ibuprofen Compared to Intravenous Ketorolac for Pain Control Following Arthroscopic Knee Surgery
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: Post Operative Pain,
Pail relief
Lead sponsor: Cumberland Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2013-07-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


Eligibility 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.

Primary outcomes:
measure: Efficacy of Pain Relief (Pain Intensity at Rest)
timeFrame: First possible time post-surgery, an expected average of 6 hours
measure: Efficacy of Pain Relief (Pain Intensity With Movement)
timeFrame: First possible time post-surgery, an expected average of 6 hours
Secondary outcomes:
measure: Rescue Medication Use in Post-operative Period
timeFrame: Post-operative period until discharge, an expected average of 6 hours
measure: Time to First Use of Rescue Med Will be Measured
timeFrame: Post-operative period until discharge, an expected average of 6 hours
measure: Patient Satisfaction
timeFrame: Post-operative period until discharge, an expected average of 6 hours
measure: Incidence of Serious Adverse Events
timeFrame: Post-operative period until discharge, an expected average of 6 hours
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: Shrock Orthopedic Research
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Tupelo
country: United States
facility: North Mississippi Sports Medicine & Orthopaedic Clinic
state: Mississippi
city: Columbus
country: United States
facility: The Ohio State University Vexner Medical Center
state: Ohio
Study officials:
affiliation: Cumberland Pharmaceuticals, Inc.
name: Arthur P Wheeler, MD
role: STUDY_DIRECTOR
References: