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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
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
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).
Time frame: 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).
Time frame: First possible time post-surgery, an expected average of 6 hours
Rescue Medication Use in Post-operative Period
Amount of rescue medication (in milligrams) will be measured
Time frame: 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.
Time frame: Post-operative period until discharge, an expected average of 6 hours
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Patient Satisfaction
Measured using 2 question, 4 point scale.
Time frame: 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
Time frame: Post-operative period until discharge, an expected average of 6 hours