Low Dose Morphine to Relieve Dyspnea in Acute Respiratory Failure (OPIDYS)

• Status: Recruiting
• Trial end date: 2021-12-19
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Morphine

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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