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

  • STATUS
    Recruiting
  • End date
    Nov 1, 2021
  • participants needed
    22
  • sponsor
    Assistance Publique - Hôpitaux de Paris
Updated on 3 February 2021

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.

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.

Details
Condition Acute Respiratory Failure
Treatment Chlorhydrate de morphine, NaCl 0,9%,
Clinical Study IdentifierNCT04358133
SponsorAssistance Publique - Hôpitaux de Paris
Last Modified on3 February 2021

Eligibility

Yes No Not Sure

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
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