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Clinical Trials/NCT01550146
NCT01550146
Unknown
Phase 4

Effects of a Single Dose of Dexamethasone in Patients Undergoing Operative Fixation of Proximal Femur Fracture

Cork University Hospital1 site in 1 country40 target enrollmentJuly 2009

Overview

Phase
Phase 4
Intervention
Dexamethasone acetate
Conditions
Fractured Neck of Femur
Sponsor
Cork University Hospital
Enrollment
40
Locations
1
Primary Endpoint
Visual analogue pain scale at rest and on movement postoperatively
Last Updated
14 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
July 2009
End Date
July 2012
Last Updated
14 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Szilard Szucs

Clinical Tutor in Anaesthesia

Cork University Hospital

Eligibility 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

Arms & Interventions

Dexamethasone, 0.1 mg/kg

The patients in the Dexamethasone group get iv 0.1 mg/kg dexamethasone preoperative.

Intervention: Dexamethasone acetate

Placebo

In the Placebo group the patients get 0.1 ml/kg normal saline.

Intervention: Placebo

Outcomes

Primary Outcomes

Visual analogue pain scale at rest and on movement postoperatively

Time Frame: Postoperative in recovery, 6, 12, 24, 48, 72 hourly

Study Sites (1)

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