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| Name | Class |
|---|---|
| Medical Metrics Diagnostics, Inc | INDUSTRY |
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A double blind prospective randomized trial of IV ketorolac vs. placebo in management of patients undergoing lumbar one or two level spinal fusions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketorolac arm | Active Comparator |
| |
| Placebo Arm | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketorolac Tromethamine | Drug | IV Ketorolac 15mg every 6 hours, x 4 doses |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Ketorolac results in decreased post-op opioid use when administered in the first 48 hours (measured by calculating the total amount of MME utilized during the patient's inpatient stay and comparing the control and experimental groups). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Ketorolac use does not decrease spinal fusion rates in one or two level fusion (failure defined as by > than 2 degrees motion on standardized flexion/extension x-rays compared to pre-op imaging analyzed by SpineCAMP software at 6 and 12 months post-op). | 12 months | |
| Ketorolac use decreases average length of hospital stay (length of stay for both the control group and the experimental group will be counted, and a statistical average for each group will be calculated and compared). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aja Janyavula | Contact | 410-427-5459 | ajanyavula@umm.edu | |
| Sam Rudow | Contact | 410-427-5459 | samuel.rudow@umm.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland St. Joseph Medical Center | Recruiting | Towson | Maryland | 21204 | United States |
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| ID | Term |
|---|---|
| D020911 | Ketorolac Tromethamine |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Placebo |
| Drug |
IV saline as placebo |
|
| 12 months |
| D006571 | Heterocyclic Compounds |