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Dexamethasone for Pain After Shoulder Surgery

This study is currently recruiting participants.
Verified November 2012 by University of Aarhus
Sponsor:
Collaborators:
Horsens Hospital
Central Denmark Region
The Family Hede Nielsens Fund
The Danish Rheumatism Association
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01414569
First received: August 9, 2011
Last updated: November 14, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Shoulder Impingement Syndrome
Arthritis
 Drug: Dexamethasone
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: High Dose Dexamethasone as Pain Treatment After Arthroscopic Shoulder Surgery: A Randomised, Blinded Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

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

Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 75
Study Start Date: November 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 8 mg dexamethasone Drug: Dexamethasone
Singe dose preoperatively in 100 ml saline intravenously
Other Name: Fortecortin
Placebo Comparator: Placebo, saline Drug: Dexamethasone
Singe dose preoperatively in 100 ml saline intravenously
Other Name: Fortecortin
Experimental: 40 mg dexamethasone Drug: Dexamethasone
Singe dose preoperatively in 100 ml saline intravenously
Other Name: Fortecortin

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01414569

Contacts
Contact: Karen T Bjørnholdt, MD +45 25544547 karenbjo@rm.dk

Locations
Denmark
Horsens Hospital Recruiting
Horsens, Denmark, DK-8700
Contact: Karen T Bjørnholdt, MD         karenbjo@rm.dk    
Sponsors and Collaborators
University of Aarhus
Horsens Hospital
Central Denmark Region
The Family Hede Nielsens Fund
The Danish Rheumatism Association
Investigators
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
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01414569     History of Changes
Other Study ID Numbers: KTB-002, 2011-003082-15
Study First Received: August 9, 2011
Last Updated: November 14, 2012
Health Authority: Denmark: Danish Medicines Agency
Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Additional relevant MeSH terms:
Arthritis
Shoulder Impingement Syndrome
Joint Diseases
Musculoskeletal Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013