A clinical trial of the effectiveness of regularly scheduled versus as-needed administration of acetaminophen in the management of discomfort in older adults with dementia

OBJECTIVES: To determine in a sample of nursing home patients with dementia and a painful condition whether the regularly scheduled administration of acetaminophen (650 mg four times a day (qid)) was more or less effective than as-needed (prn) administration of acetaminophen in reducing discomfort. DESIGN: Double-blind, double-dummy, placebo-controlled, crossover study. One arm consisted of 650 mg of acetaminophen administered qid with placebo prn; the other arm consisted of placebo administered qid with acetaminophen prn. SETTING: Two community and one Veterans Affairs nursing homes in the San Francisco Bay area. PARTICIPANTS: Thirty-nine nursing home patients with a mean+/-standard deviation Mini-Mental State Examination score of 4.3+/-5, a mean Global Deterioration Scale score of 5.7+/-0.4, and a mean Discomfort Scale score of 10.7+/-6.8. Approximately 84% had degenerative joint disease. RESULTS: Mean Discomfort Scale scores of 7.4+/-3.7 during the prn arm and 7.2+/-2.1 during the qid arm (t=0.249, nonsignificant) were within the range previously shown to indicate substantial discomfort. No significant differences in discomfort scores were found between the trial arms after controlling for baseline discomfort and prn use of acetaminophen. CONCLUSION: Although this trial was negative in terms of the analgesic effects of acetaminophen, the findings have important implications for clinical practice. Prn administration of acetaminophen is sometimes the standard of care for pain management in nursing homes or is offered as an intervention to assess effectiveness. Findings from this study suggest that a 2,600-mg/d dose of acetaminophen is inadequate for elderly nursing home patients with degenerative joint disease, fractures, or back pain who have significant discomfort.