Phase I study of safety of morphine for dyspnea in patients with interstitial lung disease
- Conditions
- Dyspnea in patients with interstitial lung disease
- Registration Number
- JPRN-UMIN000016137
- Lead Sponsor
- on-Profit Organization JORTC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 12
Not provided
1. Patients with contraindication of morphine (ex. allergy for morphine and history of severe adverse effects of morphine) 2. Patients who use opioid 3. Patients with left heart failure by echocardiography. 4. Patients with acute respiratory failure ( bacterial pneumonia, acute excerbation of interstitial pneumonia and so on). 5. Patients with active infection that causes dyspnea 6. Patients with lung cancer that causes dyspnea 7. Patients with pneumothorax 8. Patients who uses invasive positive airway pressure ventilation. Patients who uses nasal high flow were not excluded 9. Patients who changed the way of intaking of corticosteroids, immunosuppressant, bronchodilators, vasodilators and anxiolytics within two days before enrollment of the study 10. Patients who have or had drug abuse or drug dependence 11. Patients who are pregnant or possibly pregnant 12. Patients who are judged to be innapropriate for the study by the physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Respiratory depression and hypotension defined in the protocol and adverse effect >= Grade 3 (CTCAE)
- Secondary Outcome Measures
Name Time Method 1. Dyspnea NRS change between before and after morphine treatment 2. Heart rate before and after treatment 3. PaO2 and PaCO2 before and after treatment. 4. Number of vomitting 5. Derilium 6. Sedation 7. Adverse effect between 60 minutes and 24 hours after treatment.