A single arm, open label pilot study of low dose regular opioids with low dose regular benzodiazepines for the palliative relief of breathlessness for people with refractory dyspnoea.

Flinders University0 个研究点目标入组 10 人开始时间: 2010年7月21日最近更新: 2020年1月13日

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•Adults (age>18)
•Refractory dyspnoea where the underlying cause of the dyspnoea has been maximally treated.
•A medical specialist must document that all identified reversible causes of the dyspnoea are being optimally managed
•Breathlessness of a level 3 or higher on Modified Medical Research COuncil (MRC) dyspnoea scale
•On stable medications over the prior week except as needed” medications
•Prognosis of at least 2 months in the opinion of the treating clinician
•English-speaking and able to read questionnaires

•Allergic to clonazepam or to other benzodiazepines
•Severe liver disease, key results greater than three times the upper limit of normal for the local laboratory
•On regular opioid medications above the dose in the study (10 mg)
•Anemia requiring transfusion
•Confusion with a Folstein Mini-mental Status Exam <24/30.
•Severely restricted performance status with Australian Modified Karnofsky Scale score of <50 at baseline
•Uncontrolled nausea, vomiting and/or gastrointestinal obstruction.
•Renal dysfunction with creatinine clearance calculated as less than 25 mls / minute.
•Evidence of respiratory depression with resting respiratory rate less than 8 breaths per minute or a history of opioid induced respiratory depression.
•Active respiratory or cardiac event in the previous week, not including upper respiratory tract infections.
•Unable to give informed consent or complete diary entries.

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