A standardised stepwise protocol of treatment with analgesics in residents of nursing homes with moderate to severe dementia and agitation significantly improved agitation, overall neuropsychiatric symptoms, and pain. These findings emphasise the importance of assessing and treating pain effectively as part of the overall treatment and prevention of agitation and aggression in patients with dementia. The results also highlight the potential value of effective treatment of pain as a key part of reducing the use of antipsychotics and other psychotropic drugs in residents of nursing homes.
The current study is the first adequately powered parallel group randomised controlled trial of pain management for the treatment of agitation in patients with moderate to severe dementia, and the positive response is supported by the worsening of agitation over the four weeks of follow-up after the intervention had stopped. At the end of the intervention the groups differed by 7.0 points, with a 17% advantage over control in the percentage change in score on the Cohen-Mansfield agitation inventory over the duration of the trial. To put this into context, the three studies using the Cohen-Mansfield agitation inventory as an outcome in randomised controlled trials of risperidone (the only licensed drug treatment for agitation or aggression in people with dementia) reported 3%, 13%, and 18% advantages compared with placebo, respectively.25 26 27
The clinical significance of the benefit therefore compares well to the currently best available drug therapy. The clinical relevance is further supported by the significant correlation observed between change in agitation and change in pain. The results from previous open studies and case series are variable. A placebo controlled study of 167 patients in nursing homes, providing implementation of personalised, non-drug intervention, resulted in decreased agitation in the intervention group,21
but the findings were not replicated in an open study of 114 residents in nursing homes, which included pain management as part of a protocol to deal with unmet needs.13
A subsequent trial of pain treatment with paracetamol (acetaminophen) in 25 residents in nursing homes reported an increase in general activities and social interaction but no direct improvement in agitation.12
Finally, a double blind crossover trial of pain treatment with oxycodone and morphine in 47 residents in nursing homes, improved agitation in older but not in younger patients and showed a high frequency of dropouts.14
These studies show some support for the potential benefit of managing agitation by treating unmet needs such as pain, but with considerable differences in the type and magnitude of benefit, emphasising the need for a robust randomised controlled trial.11
The current, adequately powered parallel group randomised controlled trial shows more clear benefits. In clinical practice, by providing an effective treatment approach for people with dementia and agitation, improved management of pain should also help to reduce the number of prescriptions for antipsychotics in this population.
It is possible that agitation declined as a result of residents receiving sedation with opioid analgesics. However, only a few (25.6%) were treated with sedative agents (table 2), and few residents (n=3) were excluded because of drowsiness and nausea. Neither activities of daily living nor cognition worsened in the treatment group compared with control group, suggesting that sedation could not explain the reduction of agitation in the active group.
In this study, some behavioural symptoms improved in both intervention and control clusters. That may indicate a Hawthorne effect,28
perhaps related to factors such as increased staff training and support. Improvements in control groups is similar to other studies investigating drug and non-drug treatments for neuropsychiatric symptoms in people with dementia and is consistent with the potential benefits of interventions such as social interaction and reminiscence.29
Precautions were taken to blind research assistants and caregivers to group allocation, but despite these efforts these studies will always be difficult to fully blind because of the requirements in a nursing home setting.
Importantly, in the current study, active intervention conferred significantly greater benefits over and above non-specific effects. The results highlight that a standardised approach to improved pain management is a practical intervention that would be straightforward to implement widely for the benefit of agitation in residents of nursing homes with dementia.
What is already known on this topic
- Many people with dementia have painful conditions, which in people with impaired language and abstract thinking may manifest as agitation
- An estimated 180000 people with dementia in the United Kingdom are prescribed antipsychotics for agitation
What this study adds
- A standardised protocol to treat pain in residents of nursing homes with moderate to severe dementia significantly improved agitation, aggression, and pain
- Improved treatment of pain could help to reduce the unnecessary use of antipsychotics in people with dementia in nursing homes
- Standardised assessment and treatment of pain should be an integral part of the clinical management pathway for people with dementia in nursing homes