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Impact of a stepwise protocol for treating pain on pain intensity in nursing home patients with dementia: A cluster randomized trial
Author(s) -
Sandvik R.K.,
Selbaek G.,
Seifert R.,
Aarsland D.,
Ballard C.,
Corbett A.,
Husebo B.S.
Publication year - 2014
Publication title -
european journal of pain
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.305
H-Index - 109
eISSN - 1532-2149
pISSN - 1090-3801
DOI - 10.1002/ejp.523
Subject(s) - medicine , randomized controlled trial , analgesic , acetaminophen , dementia , physical therapy , pain scale , clinical trial , anesthesia , disease
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.