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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003082-15 | EudraCT Number |
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| Name | Class |
|---|---|
| Horsens Hospital | OTHER |
| Central Denmark Region | OTHER |
| The Hede Nielsen Family Foundation | OTHER |
| The Danish Rheumatism Association |
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The purpose of this study is to determine if a dose of 40 mg dexamethasone is more effective as pain treatment than the currently used dose of 8 mg after arthroscopic shoulder surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 8 mg dexamethasone | Active Comparator |
| |
| Placebo, saline | Placebo Comparator |
| |
| 40 mg dexamethasone | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | Singe dose preoperatively in 100 ml saline intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain score by numeric rating scale | At 8 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Use of analgesics | Need for supplemental analgesic medication during stay in recovery on the day of operation, until discharge. | During hospital stay, about 4 hours |
| Pain score by numeric rating scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen T Bjørnholdt, MD | Aarhus University, Horsens Hospital | Principal Investigator |
| Kjeld Søballe, Prof. dr.med. | Aarhus University Hospital | Study Chair |
| Lone Nikolajsen, ph.d., MD | Aarhus University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Horsens Hospital | Horsens | DK-8700 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24825530 | Derived | Bjornholdt KT, Monsted PN, Soballe K, Nikolajsen L. Dexamethasone for pain after outpatient shoulder surgery: a randomised, double-blind, placebo-controlled trial. Acta Anaesthesiol Scand. 2014 Jul;58(6):751-8. doi: 10.1111/aas.12333. Epub 2014 May 13. |
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| ID | Term |
|---|---|
| D019534 | Shoulder Impingement Syndrome |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070599 | Shoulder Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| C018038 | dexamethasone acetate |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| OTHER |
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On the morning of the first postoperative day, the self-evaluated level of pain as assessed by numeric rating scale.
| At about 8 a.m. on the first postoperative day |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |