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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV ibuprofen | Experimental | 800mg ibuprofen |
|
| ketorolac | Active Comparator | 30mg ketorolac |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV ibuprofen | Drug |
|
| |
| Ketorolac |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arthur P Wheeler, MD | Cumberland Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shrock Orthopedic Research | Fort Lauderdale | Florida | 33316 | United States | ||
| Rush University Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | IV Ibuprofen | 800mg ibuprofen IV ibuprofen |
| FG001 | Ketorolac | 30mg ketorolac Ketorolac |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Intent-to-Treat population consisted of all subjects who were enrolled and received at least a partial dose of investigational medicinal product.
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| ID | Title | Description |
|---|---|---|
| BG000 | IV Ibuprofen | 800mg ibuprofen IV ibuprofen |
| BG001 | Ketorolac | 30mg ketorolac Ketorolac |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | This analysis was performed on all subject who completed the VAS at Rest Immediately Following their Procedure | Posted | Mean | Standard Deviation | units on a scale (in mm) | First possible time post-surgery, an expected average of 6 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IV Ibuprofen | 800mg ibuprofen IV ibuprofen |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amy Rock, PhD | Cumberland Pharmaceutical Inc. | 615-255-0068 | arock@cumberlandpharma.com |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| D020910 | Ketorolac |
| D020911 | Ketorolac Tromethamine |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Drug |
|
|
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 |
| Chicago |
| Illinois |
| 60612 |
| United States |
| North Mississippi Sports Medicine & Orthopaedic Clinic | Tupelo | Mississippi | 38801 | United States |
| The Ohio State University Vexner Medical Center | Columbus | Ohio | 43210 | United States |
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
800mg ibuprofen
IV ibuprofen
| OG001 | Ketorolac | 30mg ketorolac Ketorolac |
|
|
| Secondary | Rescue Medication Use in Post-operative Period | Amount of rescue medication (in milligrams) will be measured | Posted | Mean | Standard Deviation | milligrams | Post-operative period until discharge, an expected average of 6 hours |
|
|
|
| Secondary | Time to First Use of Rescue Med Will be Measured | Time to first rescue medication (in hours) in the postoperative period through discharge. | Posted | Mean | Standard Error | hours | Post-operative period until discharge, an expected average of 6 hours |
|
|
|
| Secondary | Patient Satisfaction | Measured using 2 question, 4 point scale. | Posted | Number | Participants | Post-operative period until discharge, an expected average of 6 hours |
|
|
|
| Secondary | Incidence of Serious Adverse Events | Number of subjects experiencing treatment-emergent serious adverse events | Posted | Number | Number of events | Post-operative period until discharge, an expected average of 6 hours |
|
|
|
| Primary | 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). | This analysis was performed on all subject who completed the VAS with Movement Immediately Following their Procedure | Posted | Mean | Standard Deviation | units on a scale (in mm) | First possible time post-surgery, an expected average of 6 hours |
|
|
|
| 0 |
| 51 |
| 0 |
| 51 |
| EG001 | Ketorolac | 30mg ketorolac Ketorolac | 0 | 49 | 0 | 49 |
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| D010335 | Pathologic Processes |
| D007213 |
| Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Good |
|
| Excellent |
|