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


Husebo, B. S., Ballard, C., Sandvik, R., Nilsen, O. B., Aarsland, D.


BMJ (Clinical Research Ed.), Volume: 343, Pages.: d4065-d4065

Year of Publication



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.;

Bibtex Citation

@article{Husebo_2011, doi = {10.1136/bmj.d4065}, url = {}, year = 2011, month = {jul}, publisher = {{BMJ}}, volume = {343}, number = {jul15 1}, pages = {d4065--d4065}, author = {B. S. Husebo and C. Ballard and R. Sandvik and O. B. Nilsen and D. Aarsland}, title = {Efficacy of treating pain to reduce behavioural disturbances in residents of nursing homes with dementia: cluster randomised clinical trial}, journal = {{BMJ}} }


acetaminophen, aged, aged, 80 and over, agitation, analgesics, analysis of variance, and, clinical protocols, cluster analysis, dementia, female, for, homes for the aged, humans, male, nursing homes, pain, paracetamol, patch, pregabaline, prevention & control, psychology, psychomotor agitation, relief, therapeutic use, transdermal, treatment outcome

Countries of Study


Types of Dementia

Dementia (general / unspecified)

Types of Study

Cluster RCT

Type of Outcomes

ADLs/IADLs, Behaviour, Cognition, Other, Prevention and/or management of co-morbidities


Nursing Homes

Type of Interventions

Pharmaceutical Interventions, Treatment/prevention of co-morbidities or additional risks

Pharmaceutical Interventions