Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00012857
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2001-03-14
Brief Title:
Pain Management and Behavioral Outcomes in Patients With Dementia
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Pain Management and Behavioral Outcomes in Patients With Dementia
Status:
COMPLETED
Status Verified Date:
2007-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Dementia illness often co-exists with painful medical conditions associated with aging eg 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
Detailed Description:
Background
Dementia illness often co-exists with painful medical conditions associated with aging eg 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 Parkinsons 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 HSRD in August 2001
Dementia illness often co-exists with painful medical conditions associated with aging eg 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 Parkinsons 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 HSRD in August 2001
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None