Single Dose of Dexamethasone in Femur Fractures

Phase 4

• Conditions: Fractured Neck of Femur
• Interventions: Drug: Dexamethasone acetate; Drug: Placebo

• Registration Number: NCT01550146
• Lead Sponsor: Cork University Hospital

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.

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2012-01
• Status Verified: 2012-03
• Study First Submitted: 2012-03-07
• Study First Submitted QC: 2012-03-08
• Last Update Submitted: 2012-03-08
• Study First Posted: 2012-03-09
• Last Update Posted: 2012-03-09
• Study Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dexamethasone, 0.1 mg/kg	Dexamethasone acetate	The patients in the Dexamethasone group get iv 0.1 mg/kg dexamethasone preoperative.
Placebo	Placebo	In the Placebo group the patients get 0.1 ml/kg normal saline.

Primary Outcome Measures

Name	Time	Method
Visual analogue pain scale at rest and on movement postoperatively	Postoperative in recovery, 6, 12, 24, 48, 72 hourly

Trial Locations

Locations (1)

Cork University Hospital; 🇮🇪 Cork, Ireland