Single Dose of Dexamethasone in Femur Fractures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2012-07-31

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.

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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.

Conditions

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Fractured Neck of Femur

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dexamethasone, 0.1 mg/kg

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

Group Type EXPERIMENTAL

Dexamethasone acetate

Intervention Type DRUG

iv. dexamethasone 0.1 mg/kg

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

iv. Normal Saline 0.1 ml/kg

Interventions

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Dexamethasone acetate

iv. dexamethasone 0.1 mg/kg

Intervention Type DRUG

Placebo

iv. Normal Saline 0.1 ml/kg

Intervention Type DRUG

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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes