Single Dose of Dexamethasone in Femur Fractures

Fractured Neck of Femur Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01550146
• Other study ID #: 14640820
• Status: Unknown status
• Phase: Phase 4
• First received: March 7, 2012
• Last updated: March 8, 2012
• Start date: July 2009
• Est. completion date: July 2012

Study information

• Verified date: March 2012
• Source: Cork University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 40
• Est. completion date: July 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Femoral Fractures
• Femoral Neck Fractures
• Fractured Neck of Femur
• Fractures, Bone

Intervention

Drug:
• Dexamethasone acetate
iv. dexamethasone 0.1 mg/kg
• Placebo
iv. Normal Saline 0.1 ml/kg

Locations

Country	Name	City	State
Ireland	Cork University Hospital	Cork

Sponsors (2)

Lead Sponsor	Collaborator
Cork University Hospital	University of Bristol

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analogue pain scale at rest and on movement postoperatively		Postoperative in recovery, 6, 12, 24, 48, 72 hourly