Interstitial lung disease Interstitial lung disease
Conditions
Interventions
Morphine arm: single subcutaneous morphine 2 mg
Placebo arm: single subcutaneous saline 2mL
morphine
Sponsors
Matsuda Yoshinobu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients who are diagnosed with ILD by two respiratory physicians and one respiratory radiologist 2.Patients who have dyspnea at restdespite conventional treatment, with NRS 3 or more 3.Patients who have normal liver and renal function ( AST 100 IU/L or less, ALT 100 IU/L or less, T-Bil 2.0 mg/dL or less, sCre 2.0 mg/dL or less), blood oxygen saturation levels (SpO2) 90% or more and partial pressure of carbon dioxide (PaCO2) 60 Torr or less (Supplemental oxygen was allowed) 4.Adult patients (20 years old or older) 5.Patients who has expected survival of 1 month or longer 6.Patients who is capable of communication and did not have cognitive impairments 7.Patients who provided written informed consents
Exclusion criteria
Exclusion criteria: 1.Patients who have contraindication for morphine 2.Patients who use opioids 3.Patients who have left heart failure (EF < 50%) confirmed by echocardiography 4.Patients who have acute respiratory failure 5.Patients who have infection that causes dyspnea 6.Patients who have lung cancer that causes dyspnea 7.Patients who have bronchial asthma attack 8.Patients who have pneumothorax requiring thoracic drainage 9.Patients who use mechanical ventilation 10.Patients who have current or past history of drug abuse 11.Patients who are pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference of change of dyspnea at rest in NRS from baseline to 60 minutes after morphine injection between morphine arm and placebo arm | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Change of dyspnea at rest in NRS from baseline to 30 minutes after morphine or placebo injection 2.Difference of rates of patients whose dyspnea NRS decreased more than 1 between two arms 3.Respiratory rate 4.Blood pressure 5.SpO2 6.Pulse rate 7.Vomiting frequency (events/day) 8.Sedation (Richmond Agitation and Sedation Scale) 9.Other adverse events between baseline and 24 hours after injection of morphine or saline | — |
Contacts
Public ContactYoshinobu Matsuda
National Hospital Organization Kinki-Chuo Chest Medical Center
Outcome results
None listed