low-dose opiate therapy for discomfort in dementia (l-dot)

Conditions: Alzheimer Disease; Dementia; Dementia, Vascular; Pain

Summary: the purpose of this study was to determine whether a low dose an opiate pain medication is effective for the treatment of discomfort in patients with advanced dementia. the study medication was also known as lortab and contained both a narcotic pain medication and acetaminophen (the same pain medication as contained in tylenol). this study was an eight-week long clinical trial for discomfort among veterans with advanced dementia who were admitted to a nursing home care unit (nhcu) at the tuscaloosa va medical center.

objectives: the primary objective of the low-dose opiate therapy for discomfort in dementia (l-dot) project was to determine whether low-dose opiates are effective and well tolerated for the treatment of pain (as manifest by discomfort) in patients with advanced dementia. research design: this study was a two-week double-blind, double-dummy, placebo-controlled, crossover trial of low-dose hydrocodone/acetaminophen (lortab) for discomfort among veterans with a dementia, followed by six weeks of open-label therapy for patients who tolerated treatment during the first two weeks (eight weeks total treatment on study). methodology: after consent, patients over age 55 with dementia residing in a nursing home care unit (or at home who receive care) at tuscaloosa vamc who demonstrate significant discomfort (as measured by the pain assessment in advanced dementia - painad) were randomized to one of two groups, using a double-blind, double-dummy, placebo-controlled, crossover design. patients were randomly assigned to treatment with either hydrocodone/acetaminophen 2.5mg/250mg q8hrs scheduled with placebo q8hrs prn or placebo q8hrs scheduled with hydrocodone/acetaminophen 2.5mg/250mg q8hrs prn. after one week's treatment, patients were crossed over to the other (opposite) regimen, for a total of two weeks of blinded treatment. patients who tolerated treatment with hydrocodone/acetaminophen were eligible for a six-week, open-label continuation phase. the primary outcome measure was pain/discomfort. preliminary sample size calculations indicated that 42 patients (48 patients accounting for dropouts) would be needed to be enrolled over three years to detect a difference between treatments with power of .80 and two-tailed alpha of .05. significance: there is evidence that pain is both under recognized and undertreated in long term care settings. this study hoped to make a significant contribution to the evidence base for a common and problematic situation among veterans with advanced dementia. advances in pain and symptom control are central to the improvement of palliative care intervention for dementia patients. low-dose opiates are the logical next category of analgesics to consider, but have been rarely studied for this purpose in this population.

Eligibility criteria:
inclusion criteria: * 55 years of age or older; * must have a diagnosis of dementia; * advanced stage of dementia demonstrated by a score of 6 or greater on the functional assessment staging (fast) scale; * unable to report pain in a reliable and consistent manner; * have a painad score of at least 2 on two consecutive assessments (separated by at least two days) or an average painad score of at least 2 on three consecutive assessments each separated by at least two days; * the patient must have at least one medical condition associated with pain recorded on the cprs problem list. exclusion criteria: * the existence of an effective analgesia treatment regimen; * pain treatment related to angina or pain judged to be related to angina; * current pain treatment with opiates that cannot, in the opinion of the attending physician, be discontinued without placing the patient at risk for increased pain or opiate withdrawal; * current pain treatment with tramadol that cannot, in the opinion of the attending physician, be discontinued; * presence of necessary drug therapy that is incompatible with or has potential for clinically significant drug interaction with either hydrocodone or acetaminophen; * a history of allergy, hypersensitivity, or intolerance to either hydrocodone or acetaminophen; * constipation refractory to current treatment measures or a condition that would make constipation dangerous for the patient in the opinion of the attending physician; * the presence of liver disease, hepatic encephalopathy, or clinically significant elevation of liver function tests (lfts), as determined by the attending physician; * the presence of renal failure, clinically significant renal insufficiency, or clinically significant elevations of serum bun or creatinine levels, as determined by the attending physician; or * evidence, based on assessment by a geriatrician, that the apparent behavioral manifestations of discomfort are better explained by another problem (e.g., fever, infection, dehydration, delirium, psychosis)

Keywords: agitation alzheimer disease analgesics dementia narcotics opioid pain palliative care psychomotor suffering, physical