The Interactive Relationship between Pain, Psychosis, and Agitation in People with Dementia: Results from a Cluster-Randomised Clinical Trial.

Background. Neuropsychiatric symptoms are common in people with dementia, and pain is thought to be an important underlying factor. Pain has previously been associated with agitation, and pain treatment has been shown to ameliorate agitated behaviour. So far, the association between pain and psychosis and the effect of pain treatment on psychotic symptoms is unclear. Furthermore, the impact of opioid treatment on psychosis is not established. Aim. To investigate the efficacy of a stepwise protocol for treating pain (SPTP) on psychosis and agitation measured with the Neuropsychiatric Inventory, Nursing Home version, and to explore the impact of opioid analgesics on psychosis. Method. Secondary analyses are from a cluster-randomised controlled trial including 352 patients with advanced dementia and agitation from 18 nursing homes in Western Norway. The intervention group received pain treatment according to SPTP. Results. Pain was associated with disinhibition (adjusted OR: 1.21, 95% CI: 1.10-1.34) and irritability (adjusted OR: 1.10, 95% CI: 1.01-1.21) at baseline. Pain treatment reduced agitation (p < 0.001, df = 1; 300) and aberrant motor behaviour (p = 0.017, df = 1; 300). Psychosis was reduced in people with at least one symptom at baseline (p = 0.034, df = 1; 135). The use of opioid analgesics did not increase psychotic symptoms. Study Registration. This trial is registered with ClinicalTrials.gov (NCT01021696), Norwegian Medicines Agency, EudraCT (EudraCTnr: 2008-007490-20).