Low Dose Morphine to Relieve Dyspnea in Acute Respiratory Failure (OPIDYS)
- Conditions
- Acute Respiratory Failure
- Interventions
- Drug: NaCl 0,9%,
- Registration Number
- NCT04358133
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief Summary
This study evaluates a pharmacological intervention to relieve dyspnea in intensive care unit patients. Indeed, opioids can be particularly beneficial since 1) dyspnea and pain share many similarities, 2) the benefit of opioids on dyspnea has been clearly demonstrated in other populations. However, to date, data regarding the impact of morphine on dyspnea in intensive care unit patients admitted for acute respiratory failure are scarce. There may be a reluctance of physicians to prescribe opioids that is not scientifically justified.
The study will focus on patient reported outcome (PRO) criteria. The ultimate goal of this pilot study is to design the protocol of a future pragmatic trial.
- Detailed Description
Randomized, double-blind, placebo-controlled, parallel-group, single-center phase 2 pilot study.The experimental group will receive an intravenous titration of morphine followed by a subcutaneous administration of morphine hydrochloride for 24 hours according to a predefined protocol. The control group will receive placebo NaCl 0.9% administered according to the same protocol as the experimental arm Patients will be randomized 1:1 between low-dose titrated morphine (experimental group) and placebo (control group). The other treatments will be similar in both groups, according to the protocol and the recommendations.
Severe dyspnea will be assessed for regularly Patients will be followed for 48 hours: 24-hour treatment duration, evaluation of primary endpoint for first 24 hours, collection of adverse events for 48 hours.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
- Adult patients ≤ 75 years
- Admitted in intensive care for an acute respiratory failure defined as a respiratory rate> 24 / min or signs of respiratory distress such as labored breathing or paradoxical inspiration, or SpO2 <90% in ambient air
- Spontaneous ventilation, either under standard oxygen, high flow oxygen or non invasive ventilation
- Dyspnea ≥ 40 on an dyspnea-VAS from zero (no dyspnea) to 100 (worst possible dyspnea)
- Richmond agitation and sedation scale (RASS) between 0 and 2.
- No confusion, as defined by the CAM-ICU
- Signed informed consent
- Intubated patient
- Intubation planned upon admission
- Hearing or visual impairment
- Insufficient command of French
- Previous psychiatric or cognitive disorders known
- Moribund patient
- Known hypersensitivity to opioids
- Severe renal insufficiency (creatinine clearance <30 ml / min)
- Severe hepatocellular insufficiency (factor V <50%)
- Any formal contra-indication of opiates
- Opioid use within the 24 hours before inclusion
- Pregnancy or breastfeeding
- Minor and protected adult
- Exclusion period due to inclusion in another clinical trial
- Previous inclusion in this study
- No affiliation to social security
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Chlorhydrate de morphine Chlorhydrate de morphine initial dose of 2 mg, followed by 1 mg every 3 minutes until a VAS-dyspnea \<40 then relay subcut NaCl 0,9% NaCl 0,9%, initial dose of 2 mg, followed by 1 mg every 3 minutes until a VAS-dyspnea \<40 then relay subcut
- Primary Outcome Measures
Name Time Method Average dyspnea over 24 hours systematically evaluated every 4 hours over 24 hours and whenever necessary Dyspnea will be assessed by VAS-dyspnea (ranging from zero, no dyspnea to 100, worst possible dyspnea) patient reported outcome criteria (PRO).
- Secondary Outcome Measures
Name Time Method Intubation rate within the first 48 hours Intubation rate
Nausea in the first 48 hours Patient reported outcome criteria (PRO) ;min=0;max=100(worse)
Total duration of non invasive ventilation in the first 24 hours Total duration of non invasive ventilation (number of hours)
Tolerance of standard oxygen in the first 24 hours Tolerance of standard oxygen : number of adverses events
Duration of HFNCO (high-flow nasal canula oxygenation) in the first 24 hours Duration of HFNCO (number of hours)
Intensity of dyspnea every 4 hours over 24 hours patient reported outcome measure (PRO) ; min=0;max=100(worse)
Anxiety every 4 hours as well as over the first 24 hours Patient reported outcome measure (PRO) ; min=0;max=100(worse)
Duration of night sleep the first night at the end of the first night Duration of night sleep the first night (number of hours)
Severity of dry eye in the first 24 hours Patient reported outcome criteria (PRO); min=0;max=100(worse)
Incidence of severe dyspnea (dyspnea ≥40) within 24 hours patient reported outcome measure (PRO) ; min=0;max=100(worse)
Proportion of patients requiring the transition from one oxygenation technique to another At the end of the study (12 months) Proportion of patients requiring the transition from one oxygenation technique to another
Tolerance of HFNCO(high-flow nasal canula oxygenation) in the first 24 hours Tolerance of HFNCO : number of adverses events
Incidence of coma within the first 48 hours Incidence of coma
Respiratory rate every 4 hours as well as over the first 24 hours Respiratory rate
Severity of feeling of gastric distension in the first 24 hours Patient reported outcome criteria (PRO); min=0;max=100(worse)
Constipation in the first 48 hours Constipation (PRO); min=0;max=100(worse)
Number of non invasive ventilation sessions in the first 24 hours Number of non invasive ventilation sessions
Incidence of moderate to severe anxiety every 4 hours over 24 hours Incidence of moderate to severe anxiety (PRO) ; min=0;max=100(worse)
Intensity of pain every 4 hours Patient reported outcome measure (PRO) ; min=0;max=100(worse)
Quality of sleep the first night at the end of the first night Patient reported outcome measure (PRO); min=0;max=100(worse)
Nurses' adherence to the protocol in the first 24 hours Nurses' adherence to the protocol (questionnaire)
Nurses' satisfaction with the protocol in the first 24 hours Nurses' satisfaction with the protocol (questionnaire)
Tolerance of non invasive ventilation in the first 24 hours Tolerance of non invasive ventilation (PRO) ;min=0;max=100(worse)
Duration of standard oxygen in the first 24 hours Duration of standard oxygen (number of hours)
Vigilance level (Glasgow Coma Scale : impaired alertness defined by Glasgow Coma Scale ≤ 12) every 4 hours as well as the first 48 hours Vigilance level ; GCS : min=3(worse) ;max=15
Incidence of delirium within the first every 4 hours as well as over the first 48 hours Incidence of delirium
Severity of dry nose in the first 24 hours Patient reported outcome criteria (PRO); min=0;max=100(worse)
Any adverse or serious event occurring within the first 48 hours Any adverse or serious event occurring
Trial Locations
- Locations (1)
Groupe Hospitalier Pitié Salpetriere
🇫🇷Paris, France