Opioids for breathlessness in people with primary hypertension.

Phase 3

Recruiting

• Conditions: Dyspnoea in opioid naive participants with primary pulmonary hypertension.; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12609000209291
• Lead Sponsor: Flinders University - Department of Palliative and Support Services

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-04-24
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

English speaking. Participants over the age of 18.Dyspnoea secondary to maximally medically treated primary pulmonary
hypertension as assessed by the person’s respiratory physician. New York Heart Association heart failure grade III or IV.Renal function - calculated creatinine clearance >10mmol/l. Haemoglobin > 10 g/dl, or treating clinician has reviewed the haemoglobin result and confirmed that patient is on maximal treatment.On stable oxygen - no changes to prescription in the last 7 days. On stable medications – no changes to prescription medications in the last 7 days. Able to complete participant diary.Willing and able to give informed consent.

Exclusion Criteria

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.Pregnancy, risk of pregnancy or breast feeding mothers.
Past history of significant illicit opioid misuse.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The relief of breathlessness by the mean of the Dyspnoea Visual Analogue(VAS) scores. This will be calculated separately for morning (am) and evening (pm) scores.[On days 5,6and 7, and days 19,20, and 21.]