Pain Management and Behavioral Outcomes in Patients With Dementia
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Purpose
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.
| Condition | Intervention | 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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Pain Management and Behavioral Outcomes in Patients With Dementia |
| Estimated Enrollment: | 66 |
| Study Completion Date: | March 2001 |
| Arms | Assigned Interventions |
|---|---|
| Arm 1 | Drug: acetaminophen 650 mg qid and placebo qid PRN. The other arm was placebo qid and acetaminophen 650 mg qid PRN |
Detailed Description:
Background:
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.
Objectives:
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.
Methods:
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).
Status:
The study is complete. Final report was submitted to HSR&D in August 2001.
Eligibility| Ages Eligible for Study: | 55 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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:
Contacts and Locations| United States, California | |
| VA Palo Alto Health Care System | |
| Palo Alto, California, United States, 94304-1207 | |
| Principal Investigator: | Marilyn K. Douglas, DNSc RN FAAN | VA Palo Alto Health Care System |
More Information
No publications provided
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00012857 History of Changes |
| Other Study ID Numbers: | NRI 95-192 |
| Study First Received: | March 14, 2001 |
| Last Updated: | January 24, 2013 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Psychomotor Agitation Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Dyskinesias Neurologic Manifestations Psychomotor Disorders |
Neurobehavioral Manifestations Signs and Symptoms Acetaminophen Antipyretics Physiological Effects of Drugs Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013