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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.
Scientific title
RCT of analgesic medications to modify behavioural and psychological symptoms of dementia.
Secondary ID [1] 253434 0
Nil
Universal Trial Number (UTN)
U1111-1119-1070
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 260981 0
Pain 260982 0
Agitation and Agression 260983 0
Behavioural and Psychological Symptoms of Dementia 260984 0
Depression 260985 0
Condition category
Condition code
Mental Health 259117 259117 0 0
Other mental health disorders
Neurological 259120 259120 0 0
Dementias
Anaesthesiology 259121 259121 0 0
Pain management

Intervention/exposure
Study type
Interventional
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).
Intervention code [1] 257879 0
Treatment: Drugs
Intervention code [2] 257884 0
Behaviour
Comparator / control treatment
Arm 3: Placebo (pink pain mixture four times daily for two weeks. Mixture contains flavoured syrup. Given orally)
Control group
Placebo

Outcomes
Primary outcome [1] 261969 0
Agitation/Aggression (Cohen Mansfield Agitation Inventory, Pittsburgh Agitation Scale)
Timepoint [1] 261969 0
Timepoint: after two weeks of analgesic treatment
Primary outcome [2] 261970 0
Pain Scores (Abbey pain scale, PAINAD, PACSLAC)
Timepoint [2] 261970 0
Timepoint: after two weeks of analgesic treatment
Secondary outcome [1] 268897 0
Depression (Cornell depression scale)
Timepoint [1] 268897 0
Timepoint: after two weeks of analgesic treatment
Secondary outcome [2] 268898 0
Psychiatric disturbance (Neuropsychiatric Inventory)
Timepoint [2] 268898 0
Timepoint: after two weeks of analgesic treatment
Secondary outcome [3] 314836 0
Carer Burden (Zarit Burden Interview)
Timepoint [3] 314836 0
Timepoint: after two weeks of analgesic treatment

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.
Minimum age
65 Years
Maximum age
120 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Taking current analgesics, clinically unstable

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
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).
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 3539 0
3162
Recruitment postcode(s) [2] 3540 0
3004

Funding & Sponsors
Funding source category [1] 258346 0
Government body
Name [1] 258346 0
National Health and Medical Research Council
Address [1] 258346 0
GPO Box 1421
Canberra ACT 2601
Country [1] 258346 0
Australia
Primary sponsor type
Government body
Name
National Health and Medical Research Council
Address
GPO Box 1421
Canberra ACT 2601
Country
Australia
Secondary sponsor category [1] 257496 0
Other
Name [1] 257496 0
National Ageing Research Institute
Address [1] 257496 0
Po Box 2127
Royal Melbourne Hospital
Vic 3050
Country [1] 257496 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260325 0
The Alfred Ethics Committee
Ethics committee address [1] 260325 0
The Alfred Hospital
55 Commercial Road
Melbourne
VIC 3004
Ethics committee country [1] 260325 0
Australia
Date submitted for ethics approval [1] 260325 0
25/01/2011
Approval date [1] 260325 0
05/04/2011
Ethics approval number [1] 260325 0
35/11
Ethics committee name [2] 292888 0
St Vincent's Hospital (Melbourne) Human Research Ethics Committee
Ethics committee address [2] 292888 0
St Vincent's Hospital
41 Victoria Parade
Fitzroy
VIC 3065
Ethics committee country [2] 292888 0
Australia
Date submitted for ethics approval [2] 292888 0
04/06/2012
Approval date [2] 292888 0
04/07/2012
Ethics approval number [2] 292888 0
090/12
Ethics committee name [3] 292889 0
Australian Catholic University Human Research Ethics Committee
Ethics committee address [3] 292889 0
Australian Catholics University
Melbourne Campus
Locked Bag 4115
Fitzroy
VIC 3065
Ethics committee country [3] 292889 0
Australia
Date submitted for ethics approval [3] 292889 0
09/08/2013
Approval date [3] 292889 0
09/09/2013
Ethics approval number [3] 292889 0
2013 186V
Ethics committee name [4] 292890 0
Southern Health Human Research Ethics Committee
Ethics committee address [4] 292890 0
Monash Medical Centre
246 Clayton Rd
Clayton
VIC 3168
Ethics committee country [4] 292890 0
Australia
Date submitted for ethics approval [4] 292890 0
25/06/2012
Approval date [4] 292890 0
25/07/2012
Ethics approval number [4] 292890 0
12119A
Ethics committee name [5] 295023 0
Mercy Health Human Research Ethics Committee
Ethics committee address [5] 295023 0
Level 2
12 Shelley St
Richmond VIC 3121
Ethics committee country [5] 295023 0
Australia
Date submitted for ethics approval [5] 295023 0
02/06/2015
Approval date [5] 295023 0
23/11/2015
Ethics approval number [5] 295023 0
R15/30AC

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.
Trial website
Trial related presentations / publications
Pending
Public notes

Contacts
Principal investigator
Name 32105 0
Prof Stephen Gibson
Address 32105 0
National Ageing Research Institute
Gate 4, 34-54 Poplar Rd
Parkville
VIC 3052
Country 32105 0
Australia
Phone 32105 0
+61 3 8387 2329
Fax 32105 0
+61 3 9387 4030
Email 32105 0
s.gibson@nari.unimelb.edu.au
Contact person for public queries
Name 15352 0
Prof Stephen Gibson
Address 15352 0
National Ageing Research Institute
Gate 4, 34-54 Poplar Rd
Parkville
VIC 3052
Country 15352 0
Australia
Phone 15352 0
+61 3 8387 2329
Fax 15352 0
+61 3 8387 2329
Email 15352 0
s.gibson@nari.unimelb.edu.au
Contact person for scientific queries
Name 6280 0
Prof Stephen Gibson
Address 6280 0
National Ageing Research Institute
Gate 4, 34-54 Poplar Rd
Parkville
VIC 3052
Country 6280 0
Australia
Phone 6280 0
+61 3 8387 2329
Fax 6280 0
+61 3 9387 4030
Email 6280 0
s.gibson@nari.unimelb.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary