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Single Dose of Dexamethasone in Femur Fractures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01550146
Recruitment Status : Unknown
Verified March 2012 by Szilard Szucs, Cork University Hospital.
Recruitment status was:  Recruiting
First Posted : March 9, 2012
Last Update Posted : March 9, 2012
University of Bristol
Information provided by (Responsible Party):
Szilard Szucs, Cork University Hospital

Brief Summary:

Fracture neck of femur is a common cause of hospital admission in the elderly and requires operative fixation.

Dexamethasone has the potential of inhibiting cortisol secretion. In addition, preoperative glucocorticoids improve analgesia and decrease opioid consumption with reduction in associated side effects in a variety of clinical settings.

The investigators hypothesis was that a single dose of preoperative dexamethasone enhance postoperative analgesia and attenuates the inflammatory response in patients undergoing operative fixation of fractured neck of femur, in a prospective, randomized, placebo controled trial.

Condition or disease Intervention/treatment Phase
Fractured Neck of Femur Drug: Dexamethasone acetate Drug: Placebo Phase 4

Detailed Description:

Having obtained ethical approval and written informed consent from each, 40 patients scheduled to undergo operative fixation of fractured neck of femur will be randomized using sealed envelopes to two groups.

Patients in the Dexamethasone group receive a single dose of 0.1 mg/kg dexamethasone iv. preoperative, patients in the Placebo group receive the same amount of Normal Saline. The anaesthetic technique is standardized, salive samples, blood samples are taken and pain scores are measured on a visual analog scale postoperatively at several timepoints.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of a Single Dose of Dexamethasone in Patients Undergoing Operative Fixation of Proximal Femur Fracture
Study Start Date : July 2009
Actual Primary Completion Date : January 2012
Estimated Study Completion Date : July 2012

Arm Intervention/treatment
Experimental: Dexamethasone, 0.1 mg/kg
The patients in the Dexamethasone group get iv 0.1 mg/kg dexamethasone preoperative.
Drug: Dexamethasone acetate
iv. dexamethasone 0.1 mg/kg

Placebo Comparator: Placebo
In the Placebo group the patients get 0.1 ml/kg normal saline.
Drug: Placebo
iv. Normal Saline 0.1 ml/kg

Primary Outcome Measures :
  1. Visual analogue pain scale at rest and on movement postoperatively [ Time Frame: Postoperative in recovery, 6, 12, 24, 48, 72 hourly ]

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • above 65 years
  • ASA I-III patients

Exclusion Criteria:

  • patient refusal
  • outside age range
  • coagulation disorders
  • depression
  • Cushing syndrome
  • endocrine disorders
  • corticosteroid treatment in the last 4 month
  • head injury or associated injuries
  • Mini Mental Scores < 25

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01550146

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Cork University Hospital Recruiting
Cork, Ireland
Contact: Szilard Szucs, MD    +353872730724   
Contact: Gabriella Iohom, MD, PhD    +353-21-4922135   
Principal Investigator: Szilard Szucs, MD         
Sponsors and Collaborators
Cork University Hospital
University of Bristol
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Szilard Szucs, Clinical Tutor in Anaesthesia, Cork University Hospital Identifier: NCT01550146    
Other Study ID Numbers: 14640820
First Posted: March 9, 2012    Key Record Dates
Last Update Posted: March 9, 2012
Last Verified: March 2012
Keywords provided by Szilard Szucs, Cork University Hospital:
Fractured neck of femur
Additional relevant MeSH terms:
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Femoral Fractures
Fractures, Bone
Femoral Neck Fractures
Wounds and Injuries
Leg Injuries
Hip Fractures
Hip Injuries
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action