Pain Management in Geriatric Hip Fracture
This study has been completed.
Sponsor:
Queen Elizabeth Hospital, Hong Kong
Information provided by (Responsible Party):
Ho Chin Hung, Queen Elizabeth Hospital, Hong Kong
ClinicalTrials.gov Identifier:
NCT01630343
First received: June 20, 2012
Last updated: June 29, 2012
Last verified: June 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Geriatric Hip Fracture Pain Management |
Drug: Paracetamol tablet and Tramadol capsule Drug: Panadol 500mg tablet, tramadol 50mg capsule |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Efficacy of Pain Management Protocol for Elderly Hip Fracture Patients After Surgery: A Prospective Cohort Study |
Resource links provided by NLM:
Further study details as provided by Queen Elizabeth Hospital, Hong Kong:
Primary Outcome Measures:
- Functional Independency Measure(FIM) [ Time Frame: 2 years ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]It is to assess mobility in frail elderly people. A final score rangeing from 0-20 is assigned during several time-point of rehabilitation
| Enrollment: | 400 |
| Study Start Date: | January 2010 |
| Study Completion Date: | April 2012 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Regular oral Panadol and Tramadol
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.
|
Drug: Panadol 500mg tablet, tramadol 50mg capsule
Regular Panadol 500mg tds with tramadol 50mg capsule tds for 3 weeks after injury
Other Name: Endopain, tramadol
|
|
Experimental: Panadol and tramadol oral in prn basis
Control group is that patient having geriatric hip fracture will have oral analgesics ( Panadol 500mg Q4H and tramadol 50mg Q4H ) in prn basis.
|
Drug: Paracetamol tablet and Tramadol capsule
Panadol 500mg tablet Q4H prn Tramadol 50mg capsule Q4H prn
Other Name: Endpain, tramadol
|
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
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Both sex of Age > 65
- Traumatic non-pathological fracture neck of femur or trochanteric or subtrochanteric fracture having operative intervention
Exclusion Criteria:
- Age < 65
- Pathological fracture
- Multiple lower limb fractures
- Old fracture
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01630343
Please refer to this study by its ClinicalTrials.gov identifier: NCT01630343
Locations
| China | |
| Department of Orthopaedics and Traumatology, Queen Elizabeth Hospital | |
| Hong Kong SAR, China, 852 | |
Sponsors and Collaborators
Queen Elizabeth Hospital, Hong Kong
Investigators
| Study Director: | Chin Ping Hong , Raymond, FRCSE(Edin) | Queen Elizabeth Hospital |
More Information
No publications provided
| Responsible Party: | Ho Chin Hung, Associate Consultant (Orthopaedics and Traumatology), Queen Elizabeth Hospital, Hong Kong |
| ClinicalTrials.gov Identifier: | NCT01630343 History of Changes |
| Other Study ID Numbers: | QEHHIPPAIN |
| Study First Received: | June 20, 2012 |
| Last Updated: | June 29, 2012 |
| Health Authority: | Hong Kong: Ethics Committee |
Keywords provided by Queen Elizabeth Hospital, Hong Kong:
|
Geriatric hip fracture pain management |
Additional relevant MeSH terms:
|
Fractures, Bone Hip Fractures Femoral Fractures Hip Injuries Leg Injuries Wounds and Injuries Acetaminophen Tramadol Analgesics Analgesics, Non-Narcotic |
Analgesics, Opioid Antipyretics Central Nervous System Agents Central Nervous System Depressants Narcotics Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Sensory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on March 01, 2015