COPD
Conditions
Interventions
Oral morphine 3mg or 2mg every 6 hours (total six times)
Sponsors
Non-Profit Organization JORTC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Hospitalized patients with diagnosis of COPD based on the criteria of GOLD 2014 (FEV1/FVC<70%) 2. Patients with severe dyspnea at rest after standard treatment for dypnea 3. Patients aged 40 years-old or older at the time of obtaining informed consent 4. Patients with history of cigarette smoking of at least 10 pack-years 5. Patients who have the following data at baseline: AST <= 100 IU/L ALT <= 100 IU/L T-BIL <= 2.0 mg/dL eGFR >= 30 mL/min SPO2 >= 90 % (Oxygen is allowed) PaCO2 <= 60 Torr (Oxygen is allowed) 6. Patients who receive enough other treatment fo dyspnea of COPD 7. Patients with expected survival of 1 month or longer 8. Patients with lucidity and capability of communication and without cognitive inpairments 9. Patients who agree to participate the study with written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients with contraindication of morphine (ex. allergy for morphine and history of severe adverse effects of morphine) 2. Patients who use opioid. Patients who did not use codein within 3 days before study entry are eligble. 3. Patients with COPD acute exacerbation 4. Patients with active infection that causes dyspnea 5. Patients with lung cancer that causes dyspnea 6. Patients with pneumothorax 7. Patients who uses invasive positive airway pressure ventilation. Patients who uses nasal high flow were not excluded 8. Patients who changed the way of intaking of bronchodilators, corticosteroids, vasodilators and anxiolytics within two days before enrollment of the study 9. Patients who have or had drug abuse or drug dependence 10. Patients who are pregnant or possibly pregnant 11. Patients who are judged to be innapropriate for the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dyspnea NRS change between before (Day 0 evening) and after morphine treatment (Day 2 evening) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Dyspnea NRS change between before (Day 0 morning) and after morphine treatment (Day 1 morning, Day 2 morning) 2. Dyspnea NRS change between before (Day 0 evening) and after morphine treatment (Day1 evening). 3. Respiratory rate, blood puressure, SpO2 4. Sleep disturbance 5. Nausea NRS, Somnolence NRS, Anorexia NRS, 6. Nausea and constipation grade in CTCAE v4.0 7. Sedation 8. Derilium 9. Other adverse effect 10. Spontaneous bowel movement | — |
Countries
Japan
Contacts
Public ContactYoshinobu Matsuda
National Hospital Organization Kinki-Chuo Chest Medical Center Department of Psychosomatic Internal Medicine
Outcome results
None listed