Pain Management in Geriatric Hip Fracture

Geriatric Hip Fracture Pain Management Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01630343
• Other study ID #: QEHHIPPAIN
• Status: Completed
• Phase: Phase 2
• First received: June 20, 2012
• Last updated: June 29, 2012
• Start date: January 2010
• Est. completion date: April 2012

Study information

• Verified date: June 2012
• Source: Queen Elizabeth Hospital, Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Geriatric Hip Fracture Pain Management
• Hip Fractures

Intervention

Drug:
• Paracetamol tablet and Tramadol capsule
Panadol 500mg tablet Q4H prn Tramadol 50mg capsule Q4H prn
• Panadol 500mg tablet, tramadol 50mg capsule
Regular Panadol 500mg tds with tramadol 50mg capsule tds for 3 weeks after injury

Locations

Country	Name	City	State
China	Department of Orthopaedics and Traumatology, Queen Elizabeth Hospital	Hong Kong SAR

Sponsors (1)

Lead Sponsor	Collaborator
Queen Elizabeth Hospital, Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Independency Measure(FIM)	FIM including motor and cognitive function of a patient. Motor area covers self care, ambulation, bowel and bladder and etc.	2 years	No
Primary	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	2 years	No