Sixty-six patients are being recruited over a 3-year period. Sites involved in this study include the VAMC, SF, Nursing Home Care Unit (NHCU); Jewish Home for the Aged; Golden Gate Health Care Center in San Francisco; Palo Alto VA Health Care System, Nursing Home Care Units at Menlo Park and Livermore. 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 hypothesizes that patients receiving systematic, regularly scheduled pain medication will have less discomfort than the same patients receiving prn pain medication. A second hypothesis is that patients who have less discomfort will have less agitation and confusion. This study uses a randomized, double-blind, placebo-controlled, cross-over design. Each treatment arm lasts two weeks. The crossover point occurs without washout. One arm is acetaminophen 650 mg qid and placebo qid PRN. The other arm is placebo qid and acetaminophen 650 mg qid PRN. Patients are 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?s are excluded. An RA (blind to treatment arm) tests each patient for discomfort, agitation, and confusion at baseline and two times per day on two days of the week for four weeks. Nurses rate patients for agitation each shift. Repeated measures analyses will examine effect of treatment on the three behaviors (agitation, confusion, and discomfort).

Condition	Treatment or Intervention	Phase
Dementia Alzheimer Disease Pain	Drug: Acetaminophen 650	Phase II

Further Study Details: 

Expected Total Enrollment:  66

Ages Eligible for Study:  55 Years and above,  Genders Eligible for Study:  Both

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.

California
      San Francisco Medical Center, San Francisco,  California,  94121,  United States

Study ID Numbers:  NRI 95-192
Record last reviewed:  September 2000
Last Updated:  October 13, 2004
Record first received:  March 14, 2001
ClinicalTrials.gov Identifier:  NCT00012857
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08