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

NCT04358133 | Completed Phase 2

• 2 other identifiers: CRC180232019-003091-39
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Failure

Keywords

Acute respiratory failure; Dyspnea; Opioids; Comfort; Intensive care unit

Outcome Measures

Primary Outcomes (1)

• Average dyspnea over 24 hours

  Dyspnea will be assessed by VAS-dyspnea (ranging from zero, no dyspnea to 100, worst possible dyspnea) patient reported outcome criteria (PRO).

  systematically evaluated every 4 hours over 24 hours and whenever necessary

Secondary Outcomes (28)

• Intensity of dyspnea

  every 4 hours over 24 hours

• Incidence of severe dyspnea (dyspnea ≥40)

  within 24 hours

• Anxiety

  every 4 hours as well as over the first 24 hours

• Incidence of moderate to severe anxiety

  every 4 hours over 24 hours

• Intubation rate

  within the first 48 hours

Study Arms (2)

Chlorhydrate de morphine

EXPERIMENTAL

initial dose of 2 mg, followed by 1 mg every 3 minutes until a VAS-dyspnea \<40 then relay subcut

Drug: Chlorhydrate de morphine

NaCl 0,9%

PLACEBO COMPARATOR

initial dose of 2 mg, followed by 1 mg every 3 minutes until a VAS-dyspnea \<40 then relay subcut

Drug: NaCl 0,9%,

Interventions

Chlorhydrate de morphine DRUG

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

Chlorhydrate de morphine

NaCl 0,9%, DRUG

The control group will receive placebo NaCl 0.9% administered according to the same protocol as the experimental arm

NaCl 0,9%

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Pregnancy or breastfeeding
• Minor and protected adult
• No affiliation to social security

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Groupe Hospitalier Pitié Salpetriere

Paris, 75013, France

Location

Related Publications (2)

• Deleris R, Bureau C, Lebbah S, Decavele M, Dres M, Mayaux J, Similowski T, Dechartres A, Demoule A. Low dose of morphine to relieve dyspnea in acute respiratory failure: the OpiDys double-blind randomized controlled trial. Respir Res. 2024 Jul 16;25(1):280. doi: 10.1186/s12931-024-02867-2.

  PMID: 39014448 DERIVED

• Demoule A, Deleris R, Bureau C, Lebbah S, Decavele M, Dres M, Similowski T, Dechartres A. Low dose of morphine to relieve dyspnea in acute respiratory failure (OpiDys): protocol for a double-blind randomized controlled study. Trials. 2022 Sep 30;23(1):828. doi: 10.1186/s13063-022-06754-3.

  PMID: 36175968 DERIVED

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexandre DEMOULE, PH

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled, parallel-group,single center, phase 2 pilot study

Study Record Dates

• First Submitted: March 31, 2020
• First Posted: April 24, 2020
• Study Start: December 16, 2020
• Primary Completion: October 7, 2022
• Study Completion: October 7, 2022
• Last Updated: October 25, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

FR (1)