Single Dose of Dexamethasone in Femur Fractures | NCT01550146

Studies
Single Dose of Dexamethasone in Femur Fractures

NCT01550146

Sponsor

Cork University Hospital

Status

Unknown status

Last Update Posted

Mar 9, 2012Estimated

Enrollment

40Estimated

Phase

Phase 4

Conditions

Fractured Neck of Femur

Interventions

Dexamethasone acetate
Placebo

Countries

Ireland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2009

Primary Completion Date

Jan 2012Actual

Completion Date

Jul 2012Estimated

First Submitted Date

Mar 7, 2012

First Submission Date that Met QC Criteria

Mar 8, 2012

First Posted Date

Mar 9, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 8, 2012

Last Update Posted Date

Mar 9, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Szilard Szucs, Clinical Tutor in Anaesthesia, Cork University HospitalPrincipal Investigator

Lead Sponsor

Cork University HospitalOTHER

Collaborators

Name	Class
University of Bristol	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dexamethasone, 0.1 mg/kg	Experimental	The patients in the Dexamethasone group get iv 0.1 mg/kg dexamethasone preoperative.	Drug: Dexamethasone acetate
Placebo	Placebo Comparator	In the Placebo group the patients get 0.1 ml/kg normal saline.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexamethasone acetate	Drug	iv. dexamethasone 0.1 mg/kg	Dexamethasone, 0.1 mg/kg

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cork University Hospital	Recruiting	Cork	Cork		Ireland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27658581	Derived	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.

Type	Date	Date Unknown
Release	Oct 27, 2014
Reset	Oct 29, 2014

ID	Term
D006620	Hip Fractures
D005264	Femoral Fractures
D050723	Fractures, Bone
D014947	Wounds and Injuries