Single Dose of Dexamethasone in Femur Fractures

March 8, 2012 updated by: Szilard Szucs, Cork University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Cork, Ireland
        • Recruiting
        • Cork University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Szilard Szucs, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual analogue pain scale at rest and on movement postoperatively
Time Frame: Postoperative in recovery, 6, 12, 24, 48, 72 hourly
Postoperative in recovery, 6, 12, 24, 48, 72 hourly

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cork University Hospital

Collaborators

University of Bristol

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

January 1, 2012

Study Completion (Anticipated)

July 1, 2012

Study Registration Dates

First Submitted

March 7, 2012

First Submitted That Met QC Criteria

March 8, 2012

First Posted (Estimate)

March 9, 2012

Study Record Updates

Last Update Posted (Estimate)

March 9, 2012

Last Update Submitted That Met QC Criteria

March 8, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14640820

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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