A randomised, placebo-controlled, double-blind, cross-over study of the efficacy of sustained-release low dose morphine in the subjective sensation of dyspnoea as a result of maximally treated mesothelioma or asbestosis or other causes of interstitial lung disease in opioid naive participants.

Flinders University - Department of Palliative and Support Services0 个研究点目标入组 39 人开始时间: 2011年7月11日最近更新: 2022年1月31日

试验速览

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•English speaking. Participants over the age of 18.Dyspnoea (3 or greater on the Medical Research Council scale) secondary to mesothelioma,asbestosis or any other cause of restrictive type pattern of interstitial lung disease. Renal function - calculated creatinine clearance >10mmol/l. Haemoglobin > 10 g/dl, or treating clinician has reviewed the haemoglobin result and confirmed that particpant does not need a blood transfusion. On stable oxygen - no changes to prescription in the last 3 days. On stable medications – no changes to prescription medications in the last 3 days. Able to complete participant diary.Willing and able to give informed consent.

•Taking regular opioid medications.True adverse reaction(s) to morphine previously. Known hypersensitivity to any of the morphine sulphate capsule components. History of central hypoventilation syndrome.
•Use of monoamine oxidase inhibitor(s) (MAOIs) in the last 2 weeks or proposed use during the study. Australian Karnofsky Modified Performance Status (modified AKPS) < 50. Acutely confused (Nursing Delirium Assessment Scale score > 0 at baseline).Cognitive impairment (Mini-Mental State Examination < 24 at baseline). Uncontrolled nausea or vomiting.
•Gastrointestinal obstruction or documented peritoneal mesothelioma. Pregnancy, risk of pregnancy or breast feeding mothers.
•Past history of significant illicit opioid misuse.

发起方

Flinders University - Department of Palliative and Support Services