Dexamethasone for Pain After Shoulder Surgery

Arthritis Clinical Trial

Official title:

High Dose Dexamethasone as Pain Treatment After Arthroscopic Shoulder Surgery: A Randomised, Blinded Clinical Trial

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

• Arthritis
• Shoulder Impingement Syndrome

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