Single Dose of Dexamethasone in Femur Fractures

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01550146

Enrollment

Registered

2012-03-09

Start date

2009-07-31

Completion date

2012-07-31

Last updated

2012-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fractured Neck of Femur

Keywords

Fractured neck of femur, Dexamethasone

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.

Interventions

DRUGDexamethasone acetate

iv. dexamethasone 0.1 mg/kg

DRUGPlacebo

iv. Normal Saline 0.1 ml/kg

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

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

Design outcomes

Primary

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

Countries

Ireland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026