advanced cancer patients on opioids using n-of-1 trials to determine the effectiveness of paracetamol compared to placebo outcome: Difference in mean visual analog scale (VAS) for average pain over the last 24 hours on days 2 and 3 of each cycle pair.

The University of Queensland0 个研究点目标入组 10 人开始时间: 2009年10月7日最近更新: 2020年1月13日

适应症

试验速览

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•Patients aged >18 years, with: 1) a clinical diagnosis of chronic cancer-related pain (predominantly nocioceptive rather than neuropathic in origin, Leeds Assessment of Neuropathic Symptoms and Signs (LANNS) score (27) <12), with a Brief Pain Inventory (BPI) (28) average pain score of = 3; 2) a stable baseline dose of opioid (excluding codeine or tramadol) with no more than 2 breakthrough doses of opioid per day. The opioid dose will have been stable for at least 5 days prior to commencing the trial; 3) a stable dose of other regular medications for at least five days before the trial commences. Patients already on paracetamol are eligible, but must stop paracetamol 3 days before the trial; 4) no intervention eg radiotherapy, chemotherapy, surgery that might alter pain levels during the 2 weeks prior to the study period or plans to undergo such during the study period. 5) an intact small bowel (necessary for absorption of extended release preparations), no bowel obstruction 6) satisfactory liver function (Aspartate transaminase (AST), Alanine aminotransferase (ALT) = 1.5x upper limit of normal, total bilirubin within
•normal range); 7) no known allergy or sensitivity to paracetamol; 8) ability to give fully informed written consent and complete daily pain diaries.

•Patients with: 1) an alcohol intake of >3 units/day; 2) cognitive impairment that in the clinician’s opinion would preclude fully informed consent or ability to complete study requirements; 3) a poor understanding of written English; 4) life expectancy less than 6 weeks.

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