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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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The aim of this study is to directly compare the clinical outcomes of both the celecoxib and placebo groups following anterior cruciate ligament (ACL) reconstruction. The study will have short and long term goals. Validated outcome measures will aim to quantify pain control at 2 weeks after surgery, as well as knee function at 2 year follow-up. Groups will be compared using pain control scales, and functional knee outcome scores. The first null hypothesis tested by this study is that the celecoxib group experiences equal pain control compared with the placebo group. The second null hypothesis is that no knee function difference will be found between the celecoxib and placebo groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Celecoxib | Placebo Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celecoxib | Drug | The treatment group will receive 400 mg Celecoxib p.o. preoperatively and the control group will receive a placebo between 1 and 3 hours pre-op, when other standard medications are administered. The treatment group will receive 200 mg of Celecoxib orally twice per day post operatively, for a duration of 5 days based on dosing protocols shown to be well tolerated and effective in treating pain following ambulatory surgery. The control group will receive a 5 day supply of placebo pills. Both groups will receive standard post surgical narcotic prescription (Oxycodone IR 5 - 10 mg po qid prn and acetaminophen 325 - 650 mg PO qid prn |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome measure is to test the null hypothesis that Celecoxib perioperatively does not negatively influence the static testing of ACL reconstruction as measured by KT arthrometer at 2 years post op. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| The 2nd outcome tested by this study is that the celecoxib group experiences equal pain control compared with the placebo group. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Geoff Dervin, MD | The Ottawa Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ottawa Hospital | Ottawa | Ontario | K1H 8L6 | Canada |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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|
| Placebo | Drug | The treatment group will receive 400 mg Celecoxib p.o. preoperatively and the control group will receive a placebo between 1 and 3 hours pre-op, when other standard medications are administered. The treatment group will receive 200 mg of Celecoxib orally twice per day post operatively, for a duration of 5 days based on dosing protocols shown to be well tolerated and effective in treating pain following ambulatory surgery. The control group will receive a 5 day supply of placebo pills. Both groups will receive standard post surgical narcotic prescription (Oxycodone IR 5 - 10 mg po qid prn and acetaminophen 325 - 650 mg PO qid prn |
|
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |