Single Dose of Dexamethasone in Femur Fractures

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Cork University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Bristol
Information provided by (Responsible Party):
Szilard Szucs, Cork University Hospital
ClinicalTrials.gov Identifier:
NCT01550146
First received: March 7, 2012
Last updated: March 8, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Fractured Neck of Femur
Drug: Dexamethasone acetate
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of a Single Dose of Dexamethasone in Patients Undergoing Operative Fixation of Proximal Femur Fracture

Resource links provided by NLM:


Further study details as provided by Cork University Hospital:

Primary Outcome Measures:
  • Visual analogue pain scale at rest and on movement postoperatively [ Time Frame: Postoperative in recovery, 6, 12, 24, 48, 72 hourly ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: July 2009
Estimated Study Completion Date: July 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01550146

Locations
Ireland
Cork University Hospital Recruiting
Cork, Ireland
Contact: Szilard Szucs, MD    +353872730724    szilard.szucs@yahoo.ie   
Contact: Gabriella Iohom, MD, PhD    +353-21-4922135    ghspielhaupter@mac.com   
Principal Investigator: Szilard Szucs, MD         
Sponsors and Collaborators
Cork University Hospital
University of Bristol
  More Information

No publications provided

Responsible Party: Szilard Szucs, Clinical Tutor in Anaesthesia, Cork University Hospital
ClinicalTrials.gov Identifier: NCT01550146     History of Changes
Other Study ID Numbers: 14640820
Study First Received: March 7, 2012
Last Updated: March 8, 2012
Health Authority: Ireland: Medical Ethics Research Committee

Keywords provided by Cork University Hospital:
Fractured neck of femur
Dexamethasone

Additional relevant MeSH terms:
Femoral Fractures
Femoral Neck Fractures
Fractures, Bone
Hip Fractures
Leg Injuries
Wounds and Injuries
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014