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Pain relief as a treatment for agitation and aggression in persons with dementia.

RCT of analgesic medications to modify behavioural and psychological symptoms of dementia.

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611000062921
Enrollment
72
Registered
2011-01-18
Start date
2011-11-16
Completion date
2016-05-24
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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).

Sponsors

National Health and Medical Research Council
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
65 Years to 120 Years
Healthy volunteers
No

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.

Exclusion criteria

Taking current analgesics, clinically unstable

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026