Geriatric Hip Fracture Pain ManagementPhase 2NCT01630343
Pain Management in Geriatric Hip Fracture
A Phase 2 study testing Paracetamol tablet and Tramadol capsule and Panadol 500mg tablet, tramadol 50mg capsule in people with Geriatric Hip Fracture Pain Management, run by Queen Elizabeth Hospital, Hong Kong at 1 site in China.
Trial summary
The Null Hypothesis is that there is no association between Pain regime and the functional performance among geriatric patients having traumatic hip fracture. Two limbs are being assessed:1. Three weeks of regular oral Panadol and Tramadol after hip fracture 2. Oral Panadol and tramadol taking in p.r.n. basis. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Geriatric Hip Fracture Pain Management
- What is being tested?
- Paracetamol tablet and Tramadol capsule and Panadol 500mg tablet, tramadol 50mg capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- Jan 2010to Apr 2012
- Phase
- Phase 2
- 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
- No healthy volunteers
- Older adult
Who may be able to join
- Both sex of Age > 65
- Traumatic non-pathological fracture neck of femur or trochanteric or subtrochanteric fracture having operative intervention
Who cannot join
- Age < 65
- Pathological fracture
- Multiple lower limb fractures
- Old fracture
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Orthopaedics and Traumatology, Queen Elizabeth Hospital
Hong Kong SAR, 852
About this study
Official title: The Efficacy of Pain Management Protocol for Elderly Hip Fracture Patients After Surgery: A Prospective Cohort Study
The Null Hypothesis is that there is no association between Pain regime and the functional performance among geriatric patients having traumatic hip fracture. Two limbs are being assessed:1. Three weeks of regular oral Panadol and Tramadol after hip fracture 2. Oral Panadol and tramadol taking in p.r.n. basis. Functional outcome including Numerical Rate Scale for pain assessment, Functional Independency Measure and Elderly Mobility Score are chosen.
Read the detailed description
200X2 patients are recruited during two periods within the study period where regular oral analgesics is given for the first 200 patients while the rest of patient will receive oral analgesics upon demand
- Conditions
- Geriatric Hip Fracture Pain Management
- Being tested
- Paracetamol tablet and Tramadol capsule, Panadol 500mg tablet, tramadol 50mg capsule
- Keywords
- Geriatric hip fracture, pain management
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paracetamol tablet and Tramadol capsuleDrug
Also called Endpain, tramadol
Panadol 500mg tablet Q4H prn Tramadol 50mg capsule Q4H prn
Panadol 500mg tablet, tramadol 50mg capsuleDrug
Also called Endopain, tramadol
Regular Panadol 500mg tds with tramadol 50mg capsule tds for 3 weeks after injury
| Study group | Role | What they receive |
|---|---|---|
| Regular oral Panadol and Tramadol | Experimental | Geriatric (age >65) Patient having traumatic hip fracture will have three weeks of regular prescription of oral Panadol(500mg) and tramadol (50mg) three times a day. Operation will be done within 3 days usually followed by rehabilitation period. Receives: Drug: Panadol 500mg tablet, tramadol 50mg capsule |
| Panadol and tramadol oral in prn basis | Experimental | Control group is that patient having geriatric hip fracture will have oral analgesics ( Panadol 500mg Q4H and tramadol 50mg Q4H ) in prn basis. Receives: Drug: Paracetamol tablet and Tramadol capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Independency Measure(FIM)
FIM including motor and cognitive function of a patient. Motor area covers self care, ambulation, bowel and bladder and etc.
Measured: 2 years
Elderly Mobility Score
It is to assess mobility in frail elderly people. A final score rangeing from 0-20 is assigned during several time-point of rehabilitation
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2012 (estimated)
- Study startJan 2010
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geriatric Hip Fracture Pain ManagementStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Elizabeth Hospital, Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ho Chin Hung, Queen Elizabeth Hospital, Hong Kong
- Investigators
- Chin Ping Hong, Raymond, FRCSE(Edin), Study director, The Queen Elizabeth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01630343
- Sponsor's protocol ID
- QEHHIPPAIN
- Status last verified
- Jun 2012
- First submitted
- 20 Jun 2012
- Last updated
- 3 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Pain Management Protocol for Elderly Hip Fracture Patients After Surgery: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT01630343
- Acronym / sponsor ID
- QEHHIPPAIN
- Conditions
- Geriatric Hip Fracture Pain Management
- Keywords
- Geriatric hip fracture, pain management
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Queen Elizabeth Hospital, Hong KongUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 28 Jun 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.
The Null Hypothesis is that there is no association between Pain regime and the functional performance among geriatric patients having traumatic hip fracture. Two limbs are being assessed:1. Three weeks of regular oral Panadol and Tramadol after hip fracture 2. Oral Panadol and tramadol taking in p.r.n. basis. Functional outcome including Numerical Rate Scale for pain assessment, Functional Independency Measure and Elderly Mobility Score are chosen.
Detailed description
200X2 patients are recruited during two periods within the study period where regular oral analgesics is given for the first 200 patients while the rest of patient will receive oral analgesics upon demand
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regular oral Panadol and Tramadol | Experimental | Drug: Panadol 500mg tablet, tramadol 50mg capsuleGeriatric (age >65) Patient having traumatic hip fracture will have three weeks of regular prescription of oral Panadol(500mg) and tramadol (50mg) three times a day. Operation will be done within 3 days usually followed by rehabilitation period. |
| Panadol and tramadol oral in prn basis | Experimental | Drug: Paracetamol tablet and Tramadol capsuleControl group is that patient having geriatric hip fracture will have oral analgesics ( Panadol 500mg Q4H and tramadol 50mg Q4H ) in prn basis. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Both sex of Age > 65
- Traumatic non-pathological fracture neck of femur or trochanteric or subtrochanteric fracture having operative intervention
Key exclusion criteria (4 listed)
- Age < 65
- Pathological fracture
- Multiple lower limb fractures
- Old fracture
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 |
|---|---|---|
| Paracetamol tablet and Tramadol capsuleAlso: Endpain, tramadolPanadol 500mg tablet Q4H prn Tramadol 50mg capsule Q4H prn | Drug | Panadol and tramadol oral in prn basis |
| Panadol 500mg tablet, tramadol 50mg capsuleAlso: Endopain, tramadolRegular Panadol 500mg tds with tramadol 50mg capsule tds for 3 weeks after injury | Drug | Regular oral Panadol and Tramadol |
Primary outcome
Functional Independency Measure(FIM)
Time frame: 2 years
FIM including motor and cognitive function of a patient. Motor area covers self care, ambulation, bowel and bladder and etc.
Elderly Mobility Score
Time frame: 2 years
It is to assess mobility in frail elderly people. A final score rangeing from 0-20 is assigned during several time-point of rehabilitation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2012.
Related trials for Geriatric Hip Fracture Pain Management
Not yet recruiting
FICB for Hip Fracture Pain in Elderly
Hip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures), Postoperative Pain
RecruitingPhase 3
Remimazolam vs. Midazolam for Sedation and Cognitive Outcomes in Orthopedic Surgery
Postoperative Cognitive Dysfunction, Orthopedic Procedures
Not yet recruitingPhase 4
The Effect of Bupivacaine Liposome Preemptive Analgesia on Postoperative Pain and Delirium in Elderly Patients Undergoing Hip Fracture Surgery
Postoperative Delirium
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.
Chin Ping Hong, Raymond, FRCSE(Edin) study director
The Queen Elizabeth Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paracetamol tablet and Tramadol capsule and Panadol 500mg tablet, tramadol 50mg capsule in people with Geriatric Hip Fracture Pain Management, run by Queen Elizabeth Hospital, Hong Kong at 1 site in China.
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 4 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: finished, as of the sponsor's last update on 3 Jul 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 China. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Independency Measure(FIM) (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jul 2012.