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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01414569
Other study ID # KTB-002
Secondary ID 2011-003082-15
Status Completed
Phase Phase 4
First received August 9, 2011
Last updated June 3, 2013
Start date November 2011
Est. completion date June 2013

Study information

Verified date June 2013
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Medicines AgencyDenmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 97
Est. completion date June 2013
Est. primary completion date April 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- Arthroscopic subacromial decompression and/or acromioclavicular resection

- General anaesthesia

- Daysurgery, Horsens Hospital

Exclusion Criteria:

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Dexamethasone
Singe dose preoperatively in 100 ml saline intravenously

Locations

Country Name City State
Denmark Horsens Hospital Horsens

Sponsors (5)

Lead Sponsor Collaborator
University of Aarhus Central Denmark Region, Horsens Hospital, The Danish Rheumatism Association, The Family Hede Nielsens Fund

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain score by numeric rating scale At 8 hours postoperatively No
Secondary 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 No
Secondary Pain score by numeric rating scale 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 No
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