Fractured Neck of FemurPhase 4NCT01550146
Single Dose of Dexamethasone in Femur Fractures
A Phase 4 study testing Dexamethasone acetate in people with Fractured Neck of Femur, run by Cork University Hospital at 1 site in Ireland.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fractured Neck of Femur
- What is being tested?
- Dexamethasone acetate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIreland
- Study dates
- Jul 2009to Jul 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- above 65 years
- ASA I-III patients
Who cannot join
- patient refusal
- outside age range
- coagulation disorders
- depression
- Cushing syndrome
- endocrine disorders
Show all 9Show fewer
- corticosteroid treatment in the last 4 month
- head injury or associated injuries
- Mini Mental Scores < 25
Trial locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
Cork University Hospital
Cork, Cork
Szilard Szucs, MD, +353872730724, szilard.szucs@yahoo.ie
Gabriella Iohom, MD, PhD, +353-21-4922135, ghspielhaupter@mac.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Fractured Neck of Femur
- Being tested
- Dexamethasone acetate, Placebo
- Keywords
- Fractured neck of femur, Dexamethasone
- Medical subject headings
- Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone acetateDrug
iv. dexamethasone 0.1 mg/kg
PlaceboDrug
iv. Normal Saline 0.1 ml/kg
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone, 0.1 mg/kg | Experimental | The patients in the Dexamethasone group get iv 0.1 mg/kg dexamethasone preoperative. Receives: Drug: Dexamethasone acetate |
| Placebo | Placebo comparator | In the Placebo group the patients get 0.1 ml/kg normal saline. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue pain scale at rest and on movement postoperatively
Measured: Postoperative in recovery, 6, 12, 24, 48, 72 hourly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2012 (estimated)
- Study startJul 2009
- Primary completionJan 2012
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fractured Neck of FemurStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cork University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bristol
- Responsible party
- Principal investigator, Szilard Szucs, Cork University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01550146
- Sponsor's protocol ID
- 14640820
- Status last verified
- Mar 2012
- First submitted
- 7 Mar 2012
- Last updated
- 9 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27658581
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Single Dose of Dexamethasone in Patients Undergoing Operative Fixation of Proximal Femur Fracture
- ClinicalTrials.gov ID
- NCT01550146
- Acronym / sponsor ID
- 14640820
- Conditions
- Fractured Neck of Femur
- Keywords
- Fractured neck of femur, Dexamethasone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cork University HospitalUniversity, hospital or other
- Collaborators
- University of Bristol
- Study start
- Jul 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jul 2012 (estimated)
- First posted
- 9 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone, 0.1 mg/kg | Experimental | Drug: Dexamethasone acetateThe patients in the Dexamethasone group get iv 0.1 mg/kg dexamethasone preoperative. |
| Placebo | Placebo comparator | Drug: PlaceboIn the Placebo group the patients get 0.1 ml/kg normal saline. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- above 65 years
- ASA I-III patients
Key exclusion criteria (9 listed)
- patient refusal
- outside age range
- coagulation disorders
- depression
- Cushing syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone acetateiv. dexamethasone 0.1 mg/kg | Drug | Dexamethasone, 0.1 mg/kg |
| Placeboiv. Normal Saline 0.1 ml/kg | Drug | Placebo |
Primary outcome
Visual analogue pain scale at rest and on movement postoperatively
Time frame: Postoperative in recovery, 6, 12, 24, 48, 72 hourly
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2012.
- Derived from this study: PubMed 27658581Szucs 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone acetate in people with Fractured Neck of Femur, run by Cork University Hospital at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue pain scale at rest and on movement postoperatively (time frame: Postoperative in recovery, 6, 12, 24, 48, 72 hourly). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01550146, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2012.