Single Dose of Dexamethasone in Femur Fractures

Sponsor

Cork University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01550146

Collaborator

University of Bristol (Other)

Enrollment

Location

Arms

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fractured Neck of Femur	Drug: Dexamethasone acetate Drug: Placebo	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Quadruple (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

Study Start Date :

Jul 1, 2009

Actual Primary Completion Date :

Jan 1, 2012

Anticipated Study Completion Date :

Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: Placebo iv. Normal Saline 0.1 ml/kg

Arm

Intervention/Treatment

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.

Drug: Placebo

iv. Normal Saline 0.1 ml/kg

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cork University Hospital	Cork		Ireland

Sponsors and Collaborators

Cork University Hospital
University of Bristol

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Szilard Szucs, Clinical Tutor in Anaesthesia, Cork University Hospital

ClinicalTrials.gov Identifier:

NCT01550146

Other Study ID Numbers:

14640820

First Posted:

Mar 9, 2012

Last Update Posted:

Mar 9, 2012

Last Verified:

Mar 1, 2012

Keywords provided by Szilard Szucs, Clinical Tutor in Anaesthesia, Cork University Hospital

Fractured neck of femur

Dexamethasone

Additional relevant MeSH terms:

Femoral Fractures

Fractures, Bone

Femoral Neck Fractures

Dexamethasone

Dexamethasone acetate

BB 1101

Study Results

No Results Posted as of Mar 9, 2012