Pain Management in Geriatric Hip Fracture

NCT ID: NCT01630343

Last Updated: 2012-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2012-04-30

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

Conditions

Geriatric Hip Fracture Pain Management

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Panadol 500mg tablet, tramadol 50mg capsule

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Paracetamol tablet and Tramadol capsule

Intervention Type: DRUG

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

Interventions

Paracetamol tablet and Tramadol capsule

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

Intervention Type: DRUG

Panadol 500mg tablet, tramadol 50mg capsule

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

Intervention Type: DRUG

Other Intervention Names

Endpain, tramadol; Endopain, tramadol

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Queen Elizabeth Hospital, Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Ho Chin Hung

Associate Consultant (Orthopaedics and Traumatology)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chin Ping Hong, Raymond, FRCSE(Edin)

Role: STUDY_DIRECTOR

The Queen Elizabeth Hospital

Locations

Department of Orthopaedics and Traumatology, Queen Elizabeth Hospital

Hong Kong SAR, , China

Countries

China

Other Identifiers

QEHHIPPAIN

Identifier Type: -

Identifier Source: org_study_id