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Clinical Trials/NCT01630343
NCT01630343CompletedPhase 2

The Efficacy of Pain Management Protocol for Elderly Hip Fracture Patients After Surgery: A Prospective Cohort Study

Queen Elizabeth Hospital, Hong Kong1 site in 1 country400 target enrollmentStarted: January 2010Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Enrollment
400
Locations
1
Primary Endpoint
Functional Independency Measure(FIM)

Study Overview

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.

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

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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.

Intervention: Panadol 500mg tablet, tramadol 50mg capsule (Drug)

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.

Intervention: Paracetamol tablet and Tramadol capsule (Drug)

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Queen Elizabeth Hospital, Hong Kong
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ho Chin Hung

Associate Consultant (Orthopaedics and Traumatology)

Queen Elizabeth Hospital, Hong Kong

Study Sites (1)

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