Single Dose of Dexamethasone in Femur Fractures
Recruitment status was: Recruiting
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.
|Fractured Neck of Femur||Drug: Dexamethasone acetate Drug: Placebo||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Effects of a Single Dose of Dexamethasone in Patients Undergoing Operative Fixation of Proximal Femur Fracture|
- Visual analogue pain scale at rest and on movement postoperatively [ Time Frame: Postoperative in recovery, 6, 12, 24, 48, 72 hourly ]
|Study Start Date:||July 2009|
|Estimated Study Completion Date:||July 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
Experimental: Dexamethasone, 0.1 mg/kg
The patients in the Dexamethasone group get iv 0.1 mg/kg dexamethasone preoperative.
Drug: Dexamethasone acetate
iv. dexamethasone 0.1 mg/kg
Placebo Comparator: Placebo
In the Placebo group the patients get 0.1 ml/kg normal saline.
iv. Normal Saline 0.1 ml/kg
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01550146
|Cork University Hospital||Recruiting|
|Contact: Szilard Szucs, MD +353872730724 firstname.lastname@example.org|
|Contact: Gabriella Iohom, MD, PhD +353-21-4922135 email@example.com|
|Principal Investigator: Szilard Szucs, MD|