Paracetamol to enhance quality of life and daily function and to decrease care dependency in advanced dementia: A randomized, double-blind, placebo-controlled crossover trial in long-term care facilities.

Undiagnosed and untreated pain is a serious and frequent problem in persons
with advanced dementia, leading to behavioural problems. Although pain is
difficult to assess in persons with advanced dementia, the impact on quality of
life (QoL) is believed to be huge. In addition, recent studies suggest that
pain also has a negative impact on the course of activities of daily living
(ADL) function. Until now, there are no proven effective interventions on QoL
in persons with dementia living in long-term care facilities. However, several
interventions are effective in diminishing mediators of QoL (challenging
behaviour, depressed mood, sleeping disorders), including pharmacological
treatment of pain. Social participation can also be seen as an indication for
QoL, and has been shown to benefit from administration of paracetamol. However,
so far no intervention studies are available that investigated the effects of
pain management on QoL in advanced dementia directly.

The overall aim of this study is to achieve optimal QoL and ADL function in
long term care falicity (LTCF) residents with moderate to (very) severe
dementia and moderate to low QoL, and to achieve less care dependency, less
pain, challenging behaviour and antipsychotic medication use, through pain
treatment with paracetamol.

We will:
1. evaluate the effect of regularly scheduled administration of paracetamol on
QoL ;
2. evaluate the effect of paracetamol on ADL function and care dependency;
3. evaluate the effect of paracetamol on pain, change in challenging behaviour
and (antipsychotic) medication use.

A randomized, double-blind, placebo-controlled cross-over trial.

Orally administered paracetamol at a dose of 3 grams a day the first 4 weeks
(3x2 tablets of 500mg), followed by 2 weeks 2x2 +1x1 tablets a day) or
corresponding placebo. Two treatment periods of six weeks, separated by a
washout period of 7 days.

Older persons with dementia have a high probability of experiencing negative
consequences of pain, such as behavioral problems (agitation, apathy), reduced
functioning, sleep problems and depression. A recently executed randomized
controlled trial showed that good pain treatment in persons with dementia
reduced agitation, regardless of having any visible pain. Since paracetamol is
known for its analgesic effect, paracetamol can reduce the negative
consequences of pain, and thus the quality of life in persons with dementia.

The negative consequences for the participants (bitter taste of the tablets,
swallowing more tablets per day) will not outweigh the benefits mentioned above.
Side-effects could be (rarely): headache or allergy. In case of chronic use of
paracetamol (months to years) in a dosage above the recommended maximum (3-4
gram daily): liver damage, kidney damage, blood abnormalities. A safety
monitoring committee will be installed which will guard trial quality and
anticipate on serious adverse events.
This study will not interfere with standard care, diagnostics and treatment for
persons with dementia.