title: Impact of a stepwise protocol for treating pain on pain intensity in nursing home patients with dementia: a cluster randomized trial.
abstract: 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 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.
  
  
  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).
  
  
  CONCLUSIONS
  Pain medication significantly improved pain in the intervention group, with indications that acetaminophen also improved ADL function.
authors.affiliation: 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.
authors.forename: R K
authors.initials: RK
authors.lastname: Sandvik
authors.forename: G
authors.initials: G
authors.lastname: Selbaek
authors.forename: R
authors.initials: R
authors.lastname: Seifert
authors.forename: D
authors.initials: D
authors.lastname: Aarsland
authors.forename: C
authors.initials: C
authors.lastname: Ballard
authors.forename: A
authors.initials: A
authors.lastname: Corbett
authors.forename: B S
authors.initials: BS
authors.lastname: Husebo
mesh_terms: D000082:Acetaminophen / Q000627:therapeutic use*; D000203:Activities of Daily Living; D000368:Aged; D000369:Aged, 80 and over; D000700:Analgesics / Q000627:therapeutic use*; D002047:Buprenorphine / Q000627:therapeutic use*; D002985:Clinical Protocols; D003704:Dementia / Q000150:complications*; D005260:Female; D006801:Humans; D008297:Male; D009020:Morphine / Q000627:therapeutic use*; D009664:Norway; D009735:Nursing Homes; D010146:Pain / Q000150:complications / Q000188:drug therapy*; D059408:Pain Management / Q000379:methods*; D010147:Pain Measurement; D000069583:Pregabalin; D057968:Transdermal Patch; D016896:Treatment Outcome; D005680:gamma-Aminobutyric Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D000700:Analgesics; D000082:Acetaminophen; D002047:Buprenorphine; D000069583:Pregabalin; D005680:gamma-Aminobutyric Acid; D009020:Morphine