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Pain Management and Behavioral Outcomes in Patients With Dementia

Phase 2
55 Years
Not Enrolling
Dementia, Alzheimer Disease, Pain, Behavior, Agitation

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Trial Information

Pain Management and Behavioral Outcomes in Patients With Dementia


Dementia illness often co-exists with painful medical conditions associated with aging
(e.g., degenerative joint disease, osteoarthritis, skin ulcers, back pain, headaches,
cancer, or angina). While the standard practice is pain assessment for all patients, the
elderly with dementia have special needs for assessment, management, and evaluation. When
they are unable to verbalize pain, objective measurement of their discomfort are possible
manifestations of pain. No research relates systemic pain treatment with reduction of
negative problematic behaviors in patient dementia.


The objectives of this research are (1) to elucidate the relationships between pain,
discomfort, and agitation; and (2) to determine the influence that pain management has on
decreasing the outcomes of discomfort, agitation, and confusion in nursing home residents.


This study used a randomized, double-blind, placebo-controlled, cross-over design. Each
treatment arm lasted two weeks. The crossover point occurred without washout. One arm was
acetaminophen 650 mg qid and placebo qid PRN. The other arm was placebo qid and
acetaminophen 650 mg qid PRN. Sites involved in the study included the Jewish Home for the
Aged in San Francisco; Golden Gate Healthcare Center in San Francisco; Palo Alto VA Health
Care System; Nursing Home Care Unit at Livermore. Patients were included who: are > 55
years; have severe dementia; have a documented painful condition not requiring opiates or a
current medication regimen; unable to report pain consistently or reliably; be present and
accept treatment for study duration; have > 1 episode of agitation per day. Patients with
schizophrenia or severe Parkinson´┐Żs are excluded. A research assistant (blind to treatment
arm) tested each patient for discomfort, agitation, and confusion at baseline and two times
per day on two days of the week for four weeks. Nurses rated patients for agitation each
shift. Instruments included the Cohen-Mansfield Agitation Inventory, the Discomfort Scale,
and the Confusion Assessment Method. Repeated measures analyses examined effect of treatment
on the three behaviors (agitation, confusion, and discomfort).


The study is complete. Final report was submitted to HSR&D in August 2001.

Inclusion Criteria:

Patients must be: 55 years old and older, nursing home residents, a diagnosed painful that
would respond to tylenol, documented agitated behavior, a dementia diagnosis or a
functional impairment severe enough to rate a 7 on the Global Deterioration Scale, be
unable to report pain. Patients must have been residents in the nursing home for at least
1 month with a plan to stay at least 2 months.

Exclusion Criteria:

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Principal Investigator

Marilyn K. Douglas, DNSc RN FAAN

Investigator Role:

Principal Investigator

Investigator Affiliation:

VA Palo Alto Health Care System


United States: Federal Government

Study ID:

NRI 95-192



Start Date:

Completion Date:

March 2001

Related Keywords:

  • Dementia
  • Alzheimer Disease, Pain
  • Behavior, Agitation
  • Alzheimer Disease
  • Dementia
  • Psychomotor Agitation



VA Palo Alto Health Care System Palo Alto, California  94304-1207