Quality of life and paracetamol in advanced dementia (Q-PID): protocol of a randomised double-blind placebo-controlled crossover trial

BACKGROUND: No proven effective interventions on quality of life (QoL) are available for persons with dementia in a long-term care facility (LTCF). However, several interventions are effective in diminishing mediators of QoL (i.e. challenging behaviour, depressed mood, sleeping disorders), including pain treatment. Un(der)diagnosed and un(der)treated pain is a serious and frequent problem in persons with dementia. Also, although pain is difficult to assess in this group, the impact on QoL is probably considerable. There is evidence that pain has a negative impact on behaviour, mood, functioning and social participation, and benefit may be derived from use of paracetamol. Therefore, in LTCF residents with advanced dementia, this study aims to evaluate the effect of scheduled pain treatment with paracetamol on QoL, neuropsychiatric symptoms, ADL function, pain, care dependency, and (change in) use of psychotropic and pain medication. METHODS: This randomised, double-blind, placebo-controlled crossover trial will include 95 patients with: 1) age ≥ 65 years, 2) advanced dementia (Reisberg Global Deterioration Scale 5–7), and 3) QUALIDEM score ≤ 70. Exclusion criteria are the regular use of pain treatment, allergies to the study drugs, severe liver insufficiency or disease, use of > 4 units of alcohol/day, weight < 50 kg, and/or concomitant use of flucloxacillin. The two treatment periods of six weeks each (paracetamol and corresponding placebo) will be separated by a washout period of seven days. Primary outcome is effect on QoL (QUALIDEM and DS-DAT) and secondary outcome is effect on neuropsychiatric symptoms, ADL function, pain, care dependency, and (change in) use of psychotropic and pain medication (all compared to baseline). DISCUSSION: If regular treatment with paracetamol proves to be beneficial for QoL, this could have major implications for daily practice in long-term care. Information from this study may help professionals in their decision making regarding the prescription of pain medication to improve the QoL of persons with dementia and a low QoL. TRIAL REGISTRATION: The trial was registered on the Netherlands Trial Register (NTR6766); Trial registration date: 20th October, 2017.