Dexamethasone for Pain After Shoulder Surgery
High Dose Dexamethasone as Pain Treatment After Arthroscopic Shoulder Surgery: A Randomised, Blinded Clinical Trial
2 other identifiers
interventional
97
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Nov 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2011
CompletedFirst Posted
Study publicly available on registry
August 11, 2011
CompletedStudy Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedJune 4, 2013
June 1, 2013
1.4 years
August 9, 2011
June 3, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Pain score by numeric rating scale
At 8 hours postoperatively
Secondary Outcomes (2)
Use of analgesics
During hospital stay, about 4 hours
Pain score by numeric rating scale
At about 8 a.m. on the first postoperative day
Study Arms (3)
8 mg dexamethasone
ACTIVE COMPARATORPlacebo, saline
PLACEBO COMPARATOR40 mg dexamethasone
EXPERIMENTALInterventions
Singe dose preoperatively in 100 ml saline intravenously
Eligibility Criteria
You may qualify if:
- Arthroscopic subacromial decompression and/or acromioclavicular resection
- General anaesthesia
- Daysurgery, Horsens Hospital
You may not qualify if:
- Incompetent
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuslead
- Horsens Hospitalcollaborator
- Central Denmark Regioncollaborator
- The Hede Nielsen Family Foundationcollaborator
- The Danish Rheumatism Associationcollaborator
Study Sites (1)
Horsens Hospital
Horsens, DK-8700, Denmark
Related Publications (1)
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.
PMID: 24825530DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karen T Bjørnholdt, MD
Aarhus University, Horsens Hospital
- STUDY CHAIR
Kjeld Søballe, Prof. dr.med.
Aarhus University Hospital
- STUDY CHAIR
Lone Nikolajsen, ph.d., MD
Aarhus University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2011
First Posted
August 11, 2011
Study Start
November 1, 2011
Primary Completion
April 1, 2013
Study Completion
June 1, 2013
Last Updated
June 4, 2013
Record last verified: 2013-06