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To compare efficacy of oral steroid in controlling pain after TKA
To compare pain and functional outcome for oral dexamethasone 16 mg, 8 mg and pacebo in patient undergoing unilateral primary total knee arthroplasy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone 16 mg | Experimental | Dexamethasone (4mg) 4 tab oral once daily in the morning |
|
| Dexamethasone 8 mg | Active Comparator | Dexamethasone (4mg) 2 tab and placebo 2 tab oral once daily in the morning |
|
| Placebo | Placebo Comparator | Placebo 4 tab oral once daily in the morning |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone Oral | Drug | To compare oral dexamethasone 16 mg vs 8 mg vs placebo in pateints undergoing unilateral TKA |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain level | VAS for pain (0-100) at rest and on motion | 12, 24 ,36, 48, 60 and 72 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| nausea and vomiting | rate of nausea and vomiting | in the first 72 hours after surgery |
| Range of motion of the knee | Flexion and extension angle |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| department of orthopaedic surgery, Faculty of medicine, Thammasat university | Recruiting | Khlong Luang | Changwat Pathum Thani | 066 | Thailand |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| 24, 72 hours then 2, 6, 12 weeks after surgery |
| Functional outcome | Modified WOMAC score | 2, 6,12 weeks after surgery |
| Blood sugar | Fasting blood sugar level | At 8.00 am of 1, 2, 3 days after surgery |
| inflammatory level | C-reactive protein level | At 8.00 am of 1, 2, 3 days and 2 weeks after surgery |
| Wound complications | Deep and superficial wound infection, wound dehiscense | 3 months after surgery |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |