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Pain Management in Geriatric Hip Fracture

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ClinicalTrials.gov Identifier: NCT01630343
Recruitment Status : Completed
First Posted : June 28, 2012
Last Update Posted : July 3, 2012
Sponsor:
Information provided by (Responsible Party):
Ho Chin Hung, Queen Elizabeth Hospital, Hong Kong

Brief 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. Functional outcome including Numerical Rate Scale for pain assessment, Functional Independency Measure and Elderly Mobility Score are chosen.

Condition or disease Intervention/treatment Phase
Geriatric Hip Fracture Pain Management Drug: Paracetamol tablet and Tramadol capsule Drug: Panadol 500mg tablet, tramadol 50mg capsule Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy of Pain Management Protocol for Elderly Hip Fracture Patients After Surgery: A Prospective Cohort Study
Study Start Date : January 2010
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

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U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.

  2. 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



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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: June 28, 2012    Key Record Dates
Last Update Posted: July 3, 2012
Last Verified: June 2012

Keywords provided by Ho Chin Hung, Queen Elizabeth Hospital, Hong Kong:
Geriatric hip fracture
pain management

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Acetaminophen
Tramadol
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants