Pain Management and Behavioral Outcomes in Patients With Dementia
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|ClinicalTrials.gov Identifier: NCT00012857|
Recruitment Status : Completed
First Posted : March 16, 2001
Last Update Posted : April 7, 2015
|Condition or disease||Intervention/treatment||Phase|
|Dementia Alzheimer Disease, Pain Behavior, Agitation||Drug: acetaminophen 650 mg qid and placebo qid PRN. The other arm was placebo qid and acetaminophen 650 mg qid PRN||Phase 2|
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�s 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||66 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Pain Management and Behavioral Outcomes in Patients With Dementia|
|Actual Study Completion Date :||March 2001|
U.S. FDA Resources
|Arm 1||Drug: acetaminophen 650 mg qid and placebo qid PRN. The other arm was placebo qid and acetaminophen 650 mg qid PRN|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00012857
|United States, California|
|VA Palo Alto Health Care System, Palo Alto, CA|
|Palo Alto, California, United States, 94304-1290|
|Principal Investigator:||Marilyn K. Douglas, DNSc RN FAAN||VA Palo Alto Health Care System, Palo Alto, CA|