NCT01550146

Single Dose of Dexamethasone in Femur Fractures

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Cork University Hospital · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Fractured Neck of Femur

Interventions

Type	Name	Description
DRUG	Dexamethasone acetate	iv. dexamethasone 0.1 mg/kg
DRUG	Placebo	iv. Normal Saline 0.1 ml/kg

Timeline

• Start date: 2009-07-01
• Primary completion: 2012-01-01
• Completion: 2012-07-01
• First posted: 2012-03-09
• Last updated: 2012-03-09

Locations

1 site across 1 country: Ireland