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Randomized Controlled Trial Multicenter Study
Impact of a stepwise protocol for treating pain on pain intensity in nursing home patients with dementia: A cluster randomized trial.
- R K Sandvik, G Selbaek, R Seifert, D Aarsland, C Ballard, A Corbett, and B S Husebo.
- Department of Global Public Health and Primary Care, Centre for Elderly- and Nursing Home Medicine, University of Bergen, Norway; Institute for Nursing Subjects, Bergen University College, Norway; Centre for Old Age Psychiatric Research, Innlandet Hospital Trust, Ottestad, Norway.
- Eur J Pain. 2014 Nov 1; 18 (10): 1490-500.
BackgroundPain 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.MethodsThree 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 Norway, 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.ResultsThe 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).ConclusionPain medication significantly improved pain in the intervention group, with indications that acetaminophen also improved ADL function.© 2014 The Authors. European Journal of Pain published by John Wiley & Sons Ltd on behalf of European Pain Federation - EFIC®.
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