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Recent studies on molar surgery have shown that a combination of a glucocorticoid and NSAID or COX-2 selective inhibitor gives better pain relief than either of the drugs used separately. The investigators group has also shown that adding dexamethasone on top of a regimen of paracetamol, NSAID and local anesthesia resulted in 45% painfree patients at rest after ambulatory breast cancer surgery.
The goal of this study is to test the NSAID + glucocorticoid concept in ACl repair. The investigators want to evaluate whether a selective COX-2 selective inhibitor or a glucocorticoid or a combination of both drugs, as part of a multimodal analgesic regime, can provide improved pain relief and shorter hospital stay in patients undergoing outpatient ACL surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COXIB | Active Comparator | 40 mg parecoxib (Dynastat, Pfizer®) one hour before surgery and 40 mg valdecoxib (prodrug of parecoxib, Bextra, Pfizer®)were given 8 hour after surgery. After retraction of parecoxib from the market: Etoricoxib (Arcoxia, MSD) 120 mg given one hour before surgery |
|
| Dexamethasone | Active Comparator | dexamethasone 8 mg iv |
|
| COXIB and dexamethasone | Active Comparator | combination of coxib AND dexamethasone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| parecoxib, valdecoxib, etoricoxib | Drug | 40 mg parecoxib (Dynastat, Pfizer®) one hour before surgery and 40 mg valdecoxib (prodrug of parecoxib, Bextra, Pfizer®)were given 8 hour after surgery. After retraction of parecoxib from the market: Etoricoxib (Arcoxia, MSD) 120 mg given one hour before surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative VAS score at rest 24 hours after surgery | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulated opioid consumption | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vegard Dahl, PhD | Baerum Hospital | Principal Investigator |
| Ulrich J Spreng, MD | Baerum Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baerum Hospital | Rud | 1309 | Norway |
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| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| C409945 | parecoxib |
| C406224 | valdecoxib |
| D000077613 | Etoricoxib |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
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|
| Dexamethasone | Drug | 8 mg IV |
|
| parecoxib, valdecoxib, parecoxib and dexamethasone | Drug | combination of both drugs |
|
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |