Pain Management in Geriatric Hip Fracture

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Geriatric Hip Fracture Pain Management	Drug: Paracetamol tablet and Tramadol capsule; Drug: Panadol 500mg tablet, tramadol 50mg capsule	Phase 2

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	400 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	The Efficacy of Pain Management Protocol for Elderly Hip Fracture Patients After Surgery: A Prospective Cohort Study
Study Start Date :	January 2010
Actual Primary Completion Date :	April 2012
Actual Study Completion Date :	April 2012

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: 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 Name: Endpain, tramadol

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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. 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

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	65 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

Queen Elizabeth Hospital, Hong Kong

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Ho Chin Hung, Associate Consultant (Orthopaedics and Traumatology), Queen Elizabeth Hospital, Hong Kong
ClinicalTrials.gov Identifier:	NCT01630343 History of Changes
Other Study ID Numbers:	QEHHIPPAIN
First Posted:	June 28, 2012
Last Update Posted:	July 3, 2012
Last Verified:	June 2012

Keywords provided by Ho Chin Hung, Queen Elizabeth Hospital, Hong Kong:

Geriatric hip fracture; pain management

Additional relevant MeSH terms:

Fractures, Bone; Hip Fractures; Wounds and Injuries; Femoral Fractures; Hip Injuries; Leg Injuries; Acetaminophen; Tramadol; Analgesics, Non-Narcotic	Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Antipyretics; Analgesics, Opioid; Narcotics; Central Nervous System Depressants