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

Study Overview
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Brief Summary
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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)

Official Title
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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

Conditions
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Pain

Intervention / Treatment
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* Drug: IV ibuprofen
* Drug: Ketorolac


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IV ibuprofen<br>800mg ibuprofen | Drug: IV ibuprofen<br> <br> * Other names: Caldolor;|
| Active Comparator: ketorolac<br>30mg ketorolac | Drug: Ketorolac<br> <br> * Other names: Ketorolac Tromethamine;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post Operative Pain,, Pail relief