NCT01550146

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2009

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 9, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

March 9, 2012

Status Verified

March 1, 2012

Enrollment Period

2.5 years

First QC Date

March 7, 2012

Last Update Submit

March 8, 2012

Conditions

Fractured Neck of Femur

Keywords

Fractured neck of femurDexamethasone

Outcome Measures

Primary Outcomes (1)

  • Visual analogue pain scale at rest and on movement postoperatively

    Postoperative in recovery, 6, 12, 24, 48, 72 hourly

Study Arms (2)

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

Dexamethasone acetateDRUG

iv. dexamethasone 0.1 mg/kg

Dexamethasone, 0.1 mg/kg
PlaceboDRUG

iv. Normal Saline 0.1 ml/kg

Placebo

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • above 65 years
  • ASA I-III patients

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cork University Hospital

Cork, Cork, Ireland

RECRUITING

Related Publications (1)

  • 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.

    PMID: 27658581DERIVED

MeSH Terms

Conditions

Femoral Neck Fractures

Interventions

dexamethasone acetate

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Tutor in Anaesthesia

Study Record Dates

First Submitted

March 7, 2012

First Posted

March 9, 2012

Study Start

July 1, 2009

Primary Completion

January 1, 2012

Study Completion

July 1, 2012

Last Updated

March 9, 2012

Record last verified: 2012-03

Locations

IE(1)