Single Dose of Dexamethasone in Femur Fractures

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Fractured Neck of Femur

Intervention / Treatment
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* Drug: Dexamethasone acetate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexamethasone, 0.1 mg/kg<br>The patients in the Dexamethasone group get iv 0.1 mg/kg dexamethasone preoperative. | Drug: Dexamethasone acetate<br>* iv. dexamethasone 0.1 mg/kg<br>|
| Placebo Comparator: Placebo<br>In the Placebo group the patients get 0.1 ml/kg normal saline. | Drug: Placebo<br>* iv. Normal Saline 0.1 ml/kg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue pain scale at rest and on movement postoperatively |  | Postoperative in recovery, 6, 12, 24, 48, 72 hourly | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fractured neck of femur, Dexamethasone