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Pain Management in Geriatric Hip Fracture

Primary Purpose

Geriatric Hip Fracture Pain Management

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Paracetamol tablet and Tramadol capsule

Panadol 500mg tablet, tramadol 50mg capsule

About this trial

This is an interventional treatment trial for Geriatric Hip Fracture Pain Management focused on measuring Geriatric hip fracture, pain management

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Orthopaedics and Traumatology, Queen Elizabeth Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Regular oral Panadol and Tramadol

Panadol and tramadol oral in prn basis

Arm Description

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.

Control group is that patient having geriatric hip fracture will have oral analgesics ( Panadol 500mg Q4H and tramadol 50mg Q4H ) in prn basis.

Outcomes

Primary Outcome Measures

Functional Independency Measure(FIM)

FIM including motor and cognitive function of a patient. Motor area covers self care, ambulation, bowel and bladder and etc.

Elderly Mobility Score

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 Outcome Measures

Full Information

NCT ID

NCT01630343

First Posted

June 20, 2012

Last Updated

June 29, 2012

Sponsor

Queen Elizabeth Hospital, Hong Kong

1. Study Identification

Unique Protocol Identification Number

NCT01630343

Brief Title

Pain Management in Geriatric Hip Fracture

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

April 2012 (Actual)

Study Completion Date

April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Queen Elizabeth Hospital, Hong Kong

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Geriatric Hip Fracture Pain Management

Keywords

Geriatric hip fracture, pain management

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

400 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Regular oral Panadol and Tramadol

Arm Type

Experimental

Arm Description

Arm Title

Panadol and tramadol oral in prn basis

Arm Type

Experimental

Arm Description

Control group is that patient having geriatric hip fracture will have oral analgesics ( Panadol 500mg Q4H and tramadol 50mg Q4H ) in prn basis.

Intervention Type

Drug

Intervention Name(s)

Paracetamol tablet and Tramadol capsule

Other Intervention Name(s)

Endpain, tramadol

Intervention Description

Panadol 500mg tablet Q4H prn Tramadol 50mg capsule Q4H prn

Intervention Type

Drug

Intervention Name(s)

Panadol 500mg tablet, tramadol 50mg capsule

Other Intervention Name(s)

Endopain, tramadol

Intervention Description

Regular Panadol 500mg tds with tramadol 50mg capsule tds for 3 weeks after injury

Primary Outcome Measure Information:

Title

Functional Independency Measure(FIM)

Description

FIM including motor and cognitive function of a patient. Motor area covers self care, ambulation, bowel and bladder and etc.

Time Frame

2 years

Title

Elderly Mobility Score

Description

It is to assess mobility in frail elderly people. A final score rangeing from 0-20 is assigned during several time-point of rehabilitation

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chin Ping Hong, Raymond, FRCSE(Edin)

Organizational Affiliation

The Queen Elizabeth Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Department of Orthopaedics and Traumatology, Queen Elizabeth Hospital

City

Hong Kong SAR

ZIP/Postal Code

852

Country

China

12. IPD Sharing Statement

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Pain Management in Geriatric Hip Fracture

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