DENVER – A structured approach to giving pain medications to agitated nursing home residents with moderate to severe dementia – regardless of their pain scores – significantly reduced their agitation and aggression in a randomized trial.
"The assumption is that their agitation was related to pain and because they had cognitive impairment they couldn’t really express [their condition]," Dr. Nathan E. Goldstein of Mount Sinai School of Medicine, New York, said at the annual meeting of the American Academy of Hospice and Palliative Care Medicine.
Bruce Jancin/IMNG Medical Media
Dr. Nathan E. Goldstein
He was one of several experts at the meeting who singled out the Norwegian nursing home study as one of the most important scientific advances in palliative care during the past year.
Agitation and other behavioral disturbances are common in patients with dementia. Haloperidol or another antipsychotic agent is often employed as first-line therapy, but these drugs have significant side effects, particularly in elderly demented patients who are often already on many other medications.
Investigators at the University of Bergen (Norway) opted to think outside the box. They randomized 352 subjects in 60 nursing home units within 18 nursing homes to 8 weeks of pain medication delivered according to a structured protocol or to usual care. Participants had moderate to severe dementia, with a median Mini-Mental State Examination score of 7. Cluster randomization was utilized, such that all patients in a given nursing home unit were randomized to the same study arm.
The primary study end point was agitation as measured by the Cohen-Mansfield Agitation Inventory. This instrument requires nurses to rate each of 29 behaviors on a 1-7 scale, with 1 indicating the behavior is not present and 7 meaning the behavior occurs several times per hour. A score of 39 or more is considered clinically significant agitation.
The mean agitation score in the pain medication group dropped steadily from a baseline of 56.2 to a nadir of 46.9 at week 8, when the intervention ended. The mean score as assessed by blinded evaluators rebounded to 50.3 at week 12, after 4 weeks off the intervention. Agitation scores in the control group didn’t change significantly over time.
The pain treatment group also demonstrated significant decreases in overall aggression and pain scores, but no significant changes in cognition or activities of daily living. The lower a patient’s pain score at the end of treatment, the lower the aggression score.
The stepwise pain treatment protocol was based upon American Geriatrics Society guidelines. Patients who were on no analgesics or only on low-dose acetaminophen at baseline were bumped up to full-dose oral acetaminophen at a maximum of 3 g/day. Those who were on full-dose acetaminophen or low-dose morphine at baseline received short-acting oral morphine to a maximum of 20 mg/day. Patients on low-dose buprenorphine at baseline or who were unable to swallow were placed on transdermal buprenorphine at 5-10 mcg/hour. And subjects with neuropathic pain were placed on adjuvant pregabalin at a maximum daily dose of 300 mg (BMJ 2011;343:d4065 [doi: 10.1136/bmj.d4065]).
Dr. Goldstein praised the Norwegian analgesia protocol as straightforward and easy to implement.
"It could be standardized and used routinely by nursing staff based upon their assessment. This means they wouldn’t have to wait for a physician order," he observed.
The only possible hang-up is that staff education and reorientation would definitely be required to make this work, and the Norwegian investigators did not discuss how they accomplished this.
"All patients in the intervention arm received the pain medication regardless of their pain assessment. There would need to be quite a bit of culture change in nursing homes to actually implement a protocol like this," the geriatrician noted.
Dr. Eric Widera of the University of California, San Francisco, said ample evidence indicates that pain in patients with dementia is common, underrecognized, and undertreated. The Norwegian pain medication protocol overcomes these barriers in novel fashion by treating everybody.
He stressed that the reduction in agitation and aggressive behavior wasn’t accomplished by merely sedating participants. After all, 69% of subjects in the intervention arm received only full-dose acetaminophen. And of the roughly one-quarter of patients who got opioids, only three withdrew from the study due to nausea or sedation.
The randomized trial was funded by the Norwegian Research Council, the University of Bergen, and Kavli’s Center for Aging and Dementia. Dr. Goldstein and Dr. Widera reported having no financial conflicts.