ACTRN12610000589088
Withdrawn
Phase 3
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.
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Flinders University
- Enrollment
- 10
- Status
- Withdrawn
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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