Single Dose of Dexamethasone in Femur Fractures
Primary Purpose
Fractured Neck of Femur
Status
Unknown status
Phase
Phase 4
Locations
Ireland
Study Type
Interventional
Intervention
Dexamethasone acetate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Fractured Neck of Femur focused on measuring Fractured neck of femur, Dexamethasone
Eligibility Criteria
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
Sites / Locations
- Cork University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Dexamethasone, 0.1 mg/kg
Placebo
Arm Description
The patients in the Dexamethasone group get iv 0.1 mg/kg dexamethasone preoperative.
In the Placebo group the patients get 0.1 ml/kg normal saline.
Outcomes
Primary Outcome Measures
Visual analogue pain scale at rest and on movement postoperatively
Secondary Outcome Measures
Full Information
NCT ID
NCT01550146
First Posted
March 7, 2012
Last Updated
March 8, 2012
Sponsor
Cork University Hospital
Collaborators
University of Bristol
1. Study Identification
Unique Protocol Identification Number
NCT01550146
Brief Title
Single Dose of Dexamethasone in Femur Fractures
Official Title
Effects of a Single Dose of Dexamethasone in Patients Undergoing Operative Fixation of Proximal Femur Fracture
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
July 2009 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
July 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cork University Hospital
Collaborators
University of Bristol
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fractured Neck of Femur
Keywords
Fractured neck of femur, Dexamethasone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dexamethasone, 0.1 mg/kg
Arm Type
Experimental
Arm Description
The patients in the Dexamethasone group get iv 0.1 mg/kg dexamethasone preoperative.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
In the Placebo group the patients get 0.1 ml/kg normal saline.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone acetate
Intervention Description
iv. dexamethasone 0.1 mg/kg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
iv. Normal Saline 0.1 ml/kg
Primary Outcome Measure Information:
Title
Visual analogue pain scale at rest and on movement postoperatively
Time Frame
Postoperative in recovery, 6, 12, 24, 48, 72 hourly
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Cork University Hospital
City
Cork
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Szilard Szucs, MD
Phone
+353872730724
Email
szilard.szucs@yahoo.ie
First Name & Middle Initial & Last Name & Degree
Gabriella Iohom, MD, PhD
Phone
+353-21-4922135
Email
ghspielhaupter@mac.com
First Name & Middle Initial & Last Name & Degree
Szilard Szucs, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
27658581
Citation
Szucs S, Jessop D, Iohom G, Shorten GD. Postoperative analgesic effect, of preoperatively administered dexamethasone, after operative fixation of fractured neck of femur: randomised, double blinded controlled study. BMC Anesthesiol. 2016 Sep 22;16(1):79. doi: 10.1186/s12871-016-0247-5.
Results Reference
derived
Learn more about this trial
Single Dose of Dexamethasone in Femur Fractures
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