Dexamethasone for Pain After Shoulder Surgery - Tabular View

Tracking Information

First Received Date ^ICMJE

August 9, 2011

Last Updated Date

January 20, 2012

Start Date ^ICMJE

November 2011

Estimated Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Pain score by numeric rating scale [ Time Frame: At 8 hours postoperatively ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01414569 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Use of analgesics [ Time Frame: During hospital stay, about 4 hours ] [ Designated as safety issue: No ]
Need for supplemental analgesic medication during stay in recovery on the day of operation, until discharge.
Pain score by numeric rating scale [ Time Frame: At about 8 a.m. on the first postoperative day ] [ Designated as safety issue: No ]
On the morning of the first postoperative day, the self-evaluated level of pain as assessed by numeric rating scale.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Dexamethasone for Pain After Shoulder Surgery

Official Title ^ICMJE

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

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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Shoulder Impingement Syndrome
Arthritis

Intervention ^ICMJE

Drug: Dexamethasone

Singe dose preoperatively in 100 ml saline intravenously

Other Name: Fortecortin

Study Arms

Active Comparator: 8 mg dexamethasone
Intervention: Drug: Dexamethasone
Placebo Comparator: Placebo, saline
Intervention: Drug: Dexamethasone
Experimental: 40 mg dexamethasone
Intervention: Drug: Dexamethasone

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

November 2012

Estimated Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Karen T Bjørnholdt, MD

+45 25544547

karenbjo@rm.dk

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT01414569

Other Study ID Numbers ^ICMJE

KTB-002, 2011-003082-15

Has Data Monitoring Committee

Responsible Party

University of Aarhus

Study Sponsor ^ICMJE

University of Aarhus

Collaborators ^ICMJE

Horsens Hospital
Central Denmark Region
The Family Hede Nielsens Fund
The Danish Rheumatism Association

Investigators ^ICMJE

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

Information Provided By

University of Aarhus

Verification Date

January 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP