Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
97 participants
INTERVENTIONAL
2011-11-30
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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8 mg dexamethasone
Dexamethasone
Singe dose preoperatively in 100 ml saline intravenously
Placebo, saline
Dexamethasone
Singe dose preoperatively in 100 ml saline intravenously
40 mg dexamethasone
Dexamethasone
Singe dose preoperatively in 100 ml saline intravenously
Interventions
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Dexamethasone
Singe dose preoperatively in 100 ml saline intravenously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* General anaesthesia
* Daysurgery, Horsens Hospital
Exclusion Criteria
* Pregnant
* Age under 18 or over 90 years
* Allergy toward dexamethasone
* Diabetes
* Active gastric ulcer
* Untreated hypertension
* Glaucoma
* Daily use of glucocorticoids or strong opioids
* Daily use of analgesics for unrelated illness
* Myasthenia gravis
* Mitochondrial disorders
18 Years
90 Years
ALL
No
Sponsors
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Horsens Hospital
OTHER
Central Denmark Region
OTHER
The Hede Nielsen Family Foundation
OTHER
The Danish Rheumatism Association
OTHER
University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Karen T Bjørnholdt, MD
Role: PRINCIPAL_INVESTIGATOR
Aarhus University, Horsens Hospital
Kjeld Søballe, Prof. dr.med.
Role: STUDY_CHAIR
Aarhus University Hospital
Lone Nikolajsen, ph.d., MD
Role: STUDY_CHAIR
Aarhus University Hospital
Locations
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Horsens Hospital
Horsens, , Denmark
Countries
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References
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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.
Other Identifiers
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2011-003082-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
KTB-002
Identifier Type: -
Identifier Source: org_study_id
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