Pain Management in Geriatric Hip Fracture

June 29, 2012 updated by: Ho Chin Hung, Queen Elizabeth Hospital, Hong Kong

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

400

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong SAR, China, 852
        • Department of Orthopaedics and Traumatology, Queen Elizabeth Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Endpain, tramadol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 years
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Elizabeth Hospital, Hong Kong

Investigators

  • Study Director: Chin Ping Hong, Raymond, FRCSE(Edin), The Queen Elizabeth Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

June 20, 2012

First Submitted That Met QC Criteria

June 26, 2012

First Posted (Estimate)

June 28, 2012

Study Record Updates

Last Update Posted (Estimate)

July 3, 2012

Last Update Submitted That Met QC Criteria

June 29, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QEHHIPPAIN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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