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

Phase 4

Completed

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)

Recruitment & Eligibility

Inclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
IV ibuprofen	IV ibuprofen	800mg ibuprofen
ketorolac	Ketorolac	30mg ketorolac

Primary Outcome Measures

Name	Time	Method
Efficacy of Pain Relief (Pain Intensity at Rest)	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).
Efficacy of Pain Relief (Pain Intensity With Movement)	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

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

Locations (4): Shrock Orthopedic Research
🇺🇸
Fort Lauderdale, Florida, United States
Rush University Medical Center
🇺🇸
Chicago, Illinois, United States
North Mississippi Sports Medicine & Orthopaedic Clinic
🇺🇸
Tupelo, Mississippi, United States
The Ohio State University Vexner Medical Center
🇺🇸
Columbus, Ohio, United States