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Efficacy of treating pain to reduce behavioural disturbances in residents of nursing homes with dementia: cluster randomised clinical trial

BMJ 2011; 343 doi: (Published 17 July 2011) Cite this as: BMJ 2011;343:d4065
  1. Bettina S Husebo, postdoctoral fellow1,
  2. Clive Ballard, professor2,
  3. Reidun Sandvik, registered nurse1,
  4. Odd Bjarte Nilsen, statistician3,
  5. Dag Aarsland, professor4
  1. 1Department of Public Health and Primary Health Care, University of Bergen, 5020 Bergen, Norway
  2. 2Wolfson Centre for Age-Related Diseases, Wolfson Wing and Hodgkin Building, Guy’s Campus, Kings College, London SE1 1UL, UK
  3. 3Department of Psychiatry, Stavanger University Hospital, 4011 Stavanger, Norway
  4. 4Karolinska Institute, Department of Neurobiology, Care Sciences and Society, Karolinska Institute-Alzheimer Disease Research Center, Novum, Stockholm, Stavanger University Hospital, Department of Psychiatry, Stavanger, Norway, and University of Oslo, Oslo, Norway
  1. Correspondence to: C Ballard clive.ballard{at}
  • Accepted 14 May 2011


Objective To determine whether a systematic approach to the treatment of pain can reduce agitation in people with moderate to severe dementia living in nursing homes.

Design Cluster randomised controlled trial.

Setting 60 clusters (single independent nursing home units) in 18 nursing homes within five municipalities of western Norway.

Participants 352 residents with moderate to severe dementia and clinically significant behavioural disturbances randomised to a stepwise protocol for the treatment of pain for eight weeks with additional follow-up four weeks after the end of treatment (33 clusters; n=175) or to usual treatment (control, 27 clusters; n=177).

Intervention Participants in the intervention group received individual daily treatment of pain for eight weeks according to the stepwise protocol, with paracetamol (acetaminophen), morphine, buprenorphine transdermal patch, or pregabaline. The control group received usual treatment and care.

Main outcome measures Primary outcome measure was agitation (scores on Cohen-Mansfield agitation inventory). Secondary outcome measures were aggression (scores on neuropsychiatric inventory-nursing home version), pain (scores on mobilisation-observation-behaviour-intensity-dementia-2), activities of daily living, and cognition (mini-mental state examination).

Results Agitation was significantly reduced in the intervention group compared with control group after eight weeks (repeated measures analysis of covariance adjusting for baseline score, P<0.001): the average reduction in scores for agitation was 17% (treatment effect estimate −7.0, 95% confidence interval −3.7 to −10.3). Treatment of pain was also significantly beneficial for the overall severity of neuropsychiatric symptoms (−9.0, −5.5 to −12.6) and pain (−1.3, −0.8 to −1.7), but the groups did not differ significantly for activities of daily living or cognition.

Conclusion A systematic approach to the management of pain significantly reduced agitation in residents of nursing homes with moderate to severe dementia. Effective management of pain can play an important part in the treatment of agitation and could reduce the number of unnecessary prescriptions for psychotropic drugs in this population.

Trial registration NCT01021696 and Norwegian Medicines Agency EudraCTnr 2008-007490-20.


  • We thank the residents, their relatives, and nursing home staff for their willingness and motivation that made this study possible.

  • Contributors: BSH, CB, and DA conceived the study and obtained funding. All authors contributed to the study design, the carrying out of the study, and the writing of the manuscript. BSH and RS collected data. OBN and BSH contributed to the statistical analysis. BSH and DA are guarantors for the study.

  • Funding: This study was funded by the Norwegian Research Council (protocol code 189439), the University of Bergen (09/1568), and Kavli’s Research Centre for Ageing and Dementia, Haraldsplass Diakonian Hospital, Bergen, Norway.

  • Competing interests: All authors have completed the ICMJE uniform disclosure form at (available on request from the corresponding author) and declare: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.

  • Ethical approval: This study was approved by the regional committee for medical ethics, western Norway (REK-Vest 248.08). Written consent was given by all participants who had sufficient capacity. If participants did not have the capacity to give consent, written assent was provided by the next of kin in accordance with the requirements of the research ethics committee and Norwegian law at the time of the study.

  • Data sharing: No additional data available.

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