Pain Management in Geriatric Hip Fracture

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01630343

First Posted: June 28, 2012

Last Update Posted: July 3, 2012

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Ho Chin Hung, Queen Elizabeth Hospital, Hong Kong

Purpose

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	Intervention	Phase
Geriatric Hip Fracture Pain Management	Drug: Paracetamol tablet and Tramadol capsule Drug: Panadol 500mg tablet, tramadol 50mg capsule	Phase 2


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Fractures Hip Injuries and Disorders

Drug Information available for: Acetaminophen Tramadol

U.S. FDA Resources

Further study details as provided by Ho Chin Hung, Queen Elizabeth Hospital, Hong Kong:

Primary Outcome Measures:

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.
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


Enrollment:	400
Study Start Date:	January 2010
Study Completion Date:	April 2012
Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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

Eligibility

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01630343

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


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 Submitted:	June 20, 2012
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

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