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Background  Pain is frequent and distressing in people with dementia, but no randomized controlled trials have evaluated the effect of analgesic treatment on pain intensity as a key outcome.    Methods  Three hundred fifty‐two people with dementia and significant agitation from 60 nursing home units were included in this study. These units, representing 18 nursing homes in western  N orway, were randomized to a stepwise protocol of treating pain ( SPTP ) or usual care. The  SPTP  group received acetaminophen, morphine, buprenorphine transdermal patch and pregabalin for 8 weeks, with a 4‐week washout period. Medications were governed by the  SPTP  and each participant's existing prescriptions. We obtained pain intensity scores from 327 patients (intervention  n  = 164, control  n  = 163) at five time points assessed by the primary outcome measure, Mobilization‐Observation‐Behaviour‐Intensity‐Dementia‐2 ( MOBID ‐2) Pain Scale. The secondary outcome was activities of daily living ( ADL ). We used a linear intercept mixed model in a two‐way repeated measures configuration to assess change over time and between groups.    Results  The  SPTP  conferred significant benefit in  MOBID ‐2 scores compared with the control group [average treatment effect ( ATE ) −1.388;  p  < 0.001] at week 8, and  MOBID ‐2 scores worsened during the washout period ( ATE  = −0.701;  p  = 0.022). Examining different analgesic treatments, benefit was conferred to patients receiving acetaminophen compared with the controls at week 2 ( ATE  = −0.663;  p  = 0.010), continuing to increase until week 8 ( ATE  = −1.297;  p  < 0.001). Although there were no overall improvements in  ADL , an increase was seen in the group receiving acetaminophen ( ATE  = +1.0;  p  = 0.022).    Conclusion  Pain medication significantly improved pain in the intervention group, with indications that acetaminophen also improved  ADL  function.

Impact of a stepwise protocol for treating pain on pain intensity in nursing home patients with dementia: A cluster randomized trial