Pain Management in Geriatric Hip Fracture

This study has been completed.
Sponsor:
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
  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
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
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Acetaminophen
Tramadol
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Narcotics
Central Nervous System Depressants
Analgesics, Opioid

ClinicalTrials.gov processed this record on April 15, 2014