Calvin Hirsch, MD
In nursing home residents with moderate-to-severe dementia, does systematic use of analgesics reduce agitation?
Cluster-randomized controlled trial (RCT). ClinicalTrials.gov NCT01021696; Norwegian Medicines Agency EudraCTnr 2008-007490-20.
Unclear allocation concealment.*
Blinded (research assistants and caregivers in direct contact with participants during outcome assessment).*
60 nursing home units in 5 municipalities of western Norway.
352 adults ≥ 65 years of age (mean age 86 y, 75% women) who lived in one of the participating nursing homes for ≥ 4 weeks, met the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, criteria for dementia, and had clinically relevant behavioral disturbances (Cohen-Mansfield Agitation Inventory [CMAI] score ≥ 39). Exclusion criteria included expected survival < 6 months; severe psychiatric or neurologic disorder; severe aggression; severe liver or renal failure; severe injury or anemia; and allergy to acetaminophen, morphine, buprenorphine, or pregabalin.
Systematic, stepwise pain treatment for 8 weeks (n = 175) or usual care (n = 177). Pain treatment began at step 1 (oral acetaminophen, ≤ 3 g/d) or, if the patient was already receiving pain treatment, step 2 (oral morphine, ≤ 20 mg/d), step 3 (buprenorphine transdermal patch, ≤ 10 µg/h), or step 4 (oral pregabalin, ≤ 300 mg/d), with a fixed-dose regimen throughout the 8-week treatment period.
Agitation (CMAI). Secondary outcomes included pain (Mobilisation-Observation-Behaviour-Intensity-Dementia-2 [MOBID-2]).
69% of patients in the pain management group received treatment at the step 1 level, 2% at step 2, 22% at step 3, and 7% at step 4. Agitation and pain scores were lower in the pain management group than in the usual care group at week 8 (Table). At week 12 (4 weeks posttreatment), the pain management group had less pain than the usual care group, but the groups did not differ for agitation (Table).
In nursing home residents with moderate-to-severe dementia, systematic use of analgesics reduced agitation during treatment but not after treatment was stopped.
†CI defined in Glossary.
‡ Variable estimate by week of effect of intervention on score from estimated model.
§CMAI = Cohen-Mansfield Agitation Inventory. Score range 29 to 203; higher scores indicate more agitation (scores ≥ 39 usually accepted as clinically significant).
||MOBID-2 = Mobilisation-Observation-Behaviour-Intensity-Dementia-2. Score range 0 to 10; higher scores indicate more pain (scores ≥ 3 usually accepted as clinically relevant).
Calvin Hirsch. Systematic pain management reduced agitation in nursing home residents with dementia. Ann Intern Med. 2011;155:JC5–9. doi: 10.7326/0003-4819-155-10-201111150-02009
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Published: Ann Intern Med. 2011;155(10):JC5-9.
Dementia, Geriatric Medicine, Neurology.
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