A randomised double-blind multi-site parallel arm controlled trial to assess relief of breathlessness comparing fixed doses of morphine and placebo in people with refractory breathlessness.

Flinders University0 个研究点目标入组 236 人开始时间: 2009年9月16日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•Adults (age >18)
•Refractory dyspnoea where the underlying cause of the dyspnoea has been maximally treated. Refractory dyspnoea does not have a minimum duration and can have been present for any period of time. A medical specialist must document that all identified reversible causes of the dyspnoea are being optimally managed.
•Breathlessness of a level 2 or higher on the modified MRC dyspnoea scale
•On stable medications over the prior week except routine as needed” medications
•Prognosis of at least 2 months in the opinion of the treating clinician
•English-speaking and able to read study questionnaires (5th grade level)

•On regular opioid medications, including codeine preparations at or above the dose being studied in the previous 7 days.
•Anemia for which transfusion is not indicated within one month of baseline evaluation.
•Severely restricted performance status with Australian Karnofsky Performance score of <40 at baseline
•Uncontrolled nausea, vomiting and/or gastrointestinal obstruction.
•Renal dysfunction with creatinine clearance calculated as less than 25 mls/minute.
•Medical history of severe hepatic impairment defined as ‘3 times upper limit of normal for 2 or more hepatic enzymes', or clotting via International Normalisation Ratio (INR) >1.2 – not treated with warfarin.
•Evidence of respiratory depression with resting respiratory rate <8.
•Active respiratory or cardiac event in the previous week, not including upper respiratory tract infections. Illness must have resolved completely prior to baseline evaluation, as judged by a doctor involved in the care of the person.
•Documented previous respiratory failure induced by any opiate medication.
•Unable to give informed consent or complete diary entries.
•Pregnant or breastfeeding

发起方