Does paracetamol improve quality of life, discomfort, pain and neuropsychiatric symptoms in persons with advanced dementia living in long-term care facilities? A randomised double-blind placebo-controlled crossover (Q-PID) trial

Abstract

Background The objectives of this study are to determine the effects of regularly scheduled administration of paracetamol (acetaminophen) on quality of life (QoL), discomfort, pain and neuropsychiatric symptoms of persons with dementia living in long-term care facilities (LTCFs). Methods A multicentre randomised double-blind placebo-controlled crossover trial for 13 weeks (January 2018 to June 2019) in 17 LTCFs across the west of the Netherlands. Inclusion criteria were age ≥ 65 years, (advanced) dementia and a moderate to low QoL, independent of the presence of pain (QUALIDEM ≤ 70). Exclusion criteria were the use of regular pain treatment, allergies to the study medication, severe liver disease, use of > 4 units of alcohol/day, weight < 50 kg and/or concomitant use of flucloxacillin. Participants received study medication (paracetamol/placebo) in two periods of 6 weeks each (1 week in between as a wash-out period). Randomisation decided in which order participants received paracetamol and placebo. Primary outcomes included QoL (QUALIDEM) and discomfort (DS-DAT), secondary outcomes included pain (MOBID-2) and neuropsychiatric symptoms (NPI-NH). Results Ninety-five LTCF residents (mean age 83.9 years [SD 7.6], 57.9% females) were included. Repeated linear mixed models showed no difference in mean differences of QUALIDEM (paracetamol +1.3 [95% CI -1.0–3.5], placebo +1.5 [95% CI -0.7–3.8]), DS-DAT (paracetamol -0.1 [95% CI -1.4–1.2], placebo 0.6 [95 CI -0.7–1.8]), MOBID-2 (paracetamol 0.0 [95% CI -0.5–0.5], placebo -0.2 [95% CI -0.7–0.3]) and NPI-NH (paracetamol +1.5 [95% CI -2.3–5.4], placebo -2.1 [95% CI -6.0–1.7]) in favour of either paracetamol or placebo. Conclusions Compared to placebo, paracetamol showed no positive effect on QoL, discomfort, pain and neuropsychiatric symptoms in persons with advanced dementia with low QoL. It is important to find out more specifically which individual persons with advanced dementia could benefit from pain treatment with paracetamol, and for clinicians to acknowledge that a good assessment, monitoring and multidomain approach is vital for improving QoL in this vulnerable group. Trial registration Netherlands Trial Register NTR6766. Trial registration date: 20 October 2017

Management of Chronic Pain in Long-Term Care: A Systematic Review and Meta-Analysis

“…37,54,56,66,71 For pharmacological interventions, 3 studies used a nonanalgesic drug intervention, 41,44,46 and 2 studies an analgesic intervention. 39,51 Nine studies used combined interventions: 5 combining nondrug alternative and education, 40,50,74,78,82 2 combining system modifications and education, 49,60 1 combining analgesic and system modification, 59 and 1 combining analgesic drugs, nonanalgesic drugs, nondrug alternative therapies, and system modification. 63…”

“…Most included studies had significant risk of bias (Supplementary Figure 2), 85 with 42 assessed as high risk, 29e31,33e38,40,41,43,45e48,50e56,58,60,62,66e69,71,73e83 11 with some concerns, 32,42,44,49,57,59,63e65,70,72 and 2 with low risk. 39,61 The domain most commonly judged to be high risk was the risk of bias due to deviations from the intended interventions, whereas the domain regarding bias due to missing outcome data had the least risk among included studies.…”

“…38 One study used an analgesic drug intervention, in which the intervention group took paracetamol, but found no significant differences in pain between intervention and control groups (P ¼ .605). 39 One study examined a nonanalgesic drug intervention by comparing hot fomentation with Epsom salt to common salt, and found significantly decreased pain for both Epsom salt (P < .001) and common salt (P < .001) groups. 41 One trial combined exercise and education programs, 40 with the intervention group reporting significantly greater decreases in arthritis pain than the control group (P ¼ .05).…”

Improving caring quality for people with dementia in nursing homes using IPOS‐Dem: A stepped‐wedge cluster randomized controlled trial protocol

“…The individual subscale scores will be re‐calculated into a percentage score, as is usual for studies using the QUALIDEM (van Dam et al, , 2019 , 2020 ; Dichter et al, 2015 ; Gräske et al, 2014 ; Oudman & Veurink, 2014 ). We will obtain an overall score by calculating the mean of the summed percentage scores.…”

“…For this study, and like that articulated by Watson (2008), caring is defined as a moral imperative and ethical foundation of nursing. When engaging in caring, frontline staff in nursing homes are not merely performing instrumental tasks but performing conscious and intentional forms of 'being' (Turkel et al, 2018;Watson, 2008).…”