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Trial registered on ANZCTR
Registration number
ACTRN12611000062921
Ethics application status
Approved
Date submitted
18/01/2011
Date registered
18/01/2011
Date last updated
14/12/2017
Type of registration
Prospectively registered
Titles & IDs
Public title
Pain relief as a treatment for agitation and aggression in persons with dementia.
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Scientific title
RCT of analgesic medications to modify behavioural and psychological symptoms of dementia.
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Secondary ID [1]
253434
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Nil
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Universal Trial Number (UTN)
U1111-1119-1070
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Dementia
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Pain
260982
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Agitation and Agression
260983
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Behavioural and Psychological Symptoms of Dementia
260984
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Depression
260985
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Condition category
Condition code
Mental Health
259117
259117
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0
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Other mental health disorders
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Neurological
259120
259120
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0
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Dementias
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Anaesthesiology
259121
259121
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0
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Pain management
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Arm 1: Paracetamol/acetomenaphen (960mg four times daily for two weeks. Given orally as part of a pink pain mixture).
Arm 2: Codeine (30mg four times daily for two weeks. Given orally as part of a pink pain mixture).
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Intervention code [1]
257879
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Treatment: Drugs
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Intervention code [2]
257884
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Behaviour
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Comparator / control treatment
Arm 3: Placebo (pink pain mixture four times daily for two weeks. Mixture contains flavoured syrup. Given orally)
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Agitation/Aggression (Cohen Mansfield Agitation Inventory, Pittsburgh Agitation Scale)
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Assessment method [1]
261969
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Timepoint [1]
261969
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Timepoint: after two weeks of analgesic treatment
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Primary outcome [2]
261970
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Pain Scores (Abbey pain scale, PAINAD, PACSLAC)
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Assessment method [2]
261970
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Timepoint [2]
261970
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Timepoint: after two weeks of analgesic treatment
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Secondary outcome [1]
268897
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Depression (Cornell depression scale)
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Assessment method [1]
268897
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Timepoint [1]
268897
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Timepoint: after two weeks of analgesic treatment
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Secondary outcome [2]
268898
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Psychiatric disturbance (Neuropsychiatric Inventory)
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Assessment method [2]
268898
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Timepoint [2]
268898
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Timepoint: after two weeks of analgesic treatment
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Secondary outcome [3]
314836
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Carer Burden (Zarit Burden Interview)
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Assessment method [3]
314836
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Timepoint [3]
314836
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Timepoint: after two weeks of analgesic treatment
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Eligibility
Key inclusion criteria
Diagnosed with dementia or presents mild cognitive impairment, experiences some form of pain (Abbey>3), exhibits behavioural and psychological symptoms of dementia (CMAI>12), normal liver and kidney function.
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Minimum age
65
Years
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Maximum age
120
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Taking current analgesics, clinically unstable
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was concealed involved contacting the holder of the allocation schedule who was “off-site” or at central administration site. Telephone service
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/03/2011
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Actual
16/11/2011
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Date of last participant enrolment
Anticipated
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Actual
24/05/2016
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Date of last data collection
Anticipated
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Actual
17/08/2016
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Sample size
Target
90
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Accrual to date
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Final
72
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment postcode(s) [1]
3539
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3162
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Recruitment postcode(s) [2]
3540
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3004
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Funding & Sponsors
Funding source category [1]
258346
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Government body
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Name [1]
258346
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National Health and Medical Research Council
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Address [1]
258346
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GPO Box 1421
Canberra ACT 2601
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Country [1]
258346
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Australia
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Primary sponsor type
Government body
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Name
National Health and Medical Research Council
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Address
GPO Box 1421
Canberra ACT 2601
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Country
Australia
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Secondary sponsor category [1]
257496
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Other
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Name [1]
257496
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National Ageing Research Institute
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Address [1]
257496
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Po Box 2127
Royal Melbourne Hospital
Vic 3050
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Country [1]
257496
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
260325
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The Alfred Ethics Committee
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Ethics committee address [1]
260325
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The Alfred Hospital
55 Commercial Road
Melbourne
VIC 3004
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Ethics committee country [1]
260325
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Australia
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Date submitted for ethics approval [1]
260325
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25/01/2011
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Approval date [1]
260325
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05/04/2011
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Ethics approval number [1]
260325
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35/11
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Ethics committee name [2]
292888
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St Vincent's Hospital (Melbourne) Human Research Ethics Committee
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Ethics committee address [2]
292888
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St Vincent's Hospital
41 Victoria Parade
Fitzroy
VIC 3065
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Ethics committee country [2]
292888
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Australia
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Date submitted for ethics approval [2]
292888
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04/06/2012
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Approval date [2]
292888
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04/07/2012
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Ethics approval number [2]
292888
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090/12
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Ethics committee name [3]
292889
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Australian Catholic University Human Research Ethics Committee
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Ethics committee address [3]
292889
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Australian Catholics University
Melbourne Campus
Locked Bag 4115
Fitzroy
VIC 3065
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Ethics committee country [3]
292889
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Australia
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Date submitted for ethics approval [3]
292889
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09/08/2013
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Approval date [3]
292889
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09/09/2013
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Ethics approval number [3]
292889
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2013 186V
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Ethics committee name [4]
292890
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Southern Health Human Research Ethics Committee
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Ethics committee address [4]
292890
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Monash Medical Centre
246 Clayton Rd
Clayton
VIC 3168
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Ethics committee country [4]
292890
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Australia
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Date submitted for ethics approval [4]
292890
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25/06/2012
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Approval date [4]
292890
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25/07/2012
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Ethics approval number [4]
292890
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12119A
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Ethics committee name [5]
295023
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Mercy Health Human Research Ethics Committee
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Ethics committee address [5]
295023
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Level 2
12 Shelley St
Richmond VIC 3121
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Ethics committee country [5]
295023
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Australia
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Date submitted for ethics approval [5]
295023
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02/06/2015
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Approval date [5]
295023
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23/11/2015
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Ethics approval number [5]
295023
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R15/30AC
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Summary
Brief summary
Behavioural and psychological symptoms of dementia (BPSD), particularly agitation and aggressive behaviours, are a major cause of distress and are often difficult to manage. Treatment of BPSD is currently focused on suppression of symptoms rather than addressing the triggering factors. Unrelieved pain is very common in older persons in residential aged care facilities and is considered to be a particularly important target within the context of ameliorating BPSD.
There have been relatively few studies to examine systematically the relationship between pain and agitation/aggression, as well as other specific types of BPSD, and the evidence for a causal association between these very common conditions is currently lacking.
The overall aim of the present study is to undertake a randomised controlled trial of analgesic interventions to specifically monitor changes in pain and consequent changes in the frequency of agitation/aggression and other BPSD in persons with dementia.
By completion, we will have important new insights into the strength of causal relationship between pain, aggression/agitation and other types of BPSD (ie. depression), and the first ever evidence on the use of analgesics to relieve pain in older cognitively impaired adults and thereby reduce the frequency of various BPSD.
The improved evidence base will help guide future clinical management of agitation/aggression and other BPSD and ultimately contribute to an improved quality of life for persons with dementia and a reduced burden of care and carer stress.
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Trial website
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Trial related presentations / publications
Pending
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Public notes
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Contacts
Principal investigator
Name
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Prof Stephen Gibson
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Address
32105
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National Ageing Research Institute
Gate 4, 34-54 Poplar Rd
Parkville
VIC 3052
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Country
32105
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Australia
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Phone
32105
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+61 3 8387 2329
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Fax
32105
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+61 3 9387 4030
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Email
32105
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[email protected]
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Contact person for public queries
Name
15352
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Prof Stephen Gibson
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Address
15352
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National Ageing Research Institute
Gate 4, 34-54 Poplar Rd
Parkville
VIC 3052
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Country
15352
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Australia
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Phone
15352
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+61 3 8387 2329
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Fax
15352
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+61 3 8387 2329
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Email
15352
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[email protected]
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Contact person for scientific queries
Name
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Prof Stephen Gibson
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Address
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National Ageing Research Institute
Gate 4, 34-54 Poplar Rd
Parkville
VIC 3052
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Country
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Australia
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Phone
6280
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+61 3 8387 2329
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Fax
6280
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+61 3 9387 4030
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Email
6280
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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