Single Dose of Dexamethasone in Femur Fractures

Cork University Hospital

Status and phase: Unknown; Phase 4

Conditions: Fractured Neck of Femur

Treatments: Drug: Dexamethasone acetate; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01550146

14640820

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Dexamethasone, 0.1 mg/kg

Experimental group

Description:

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

Treatment:

Drug: Dexamethasone acetate

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo