<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03257319</url>
  </required_header>
  <id_info>
    <org_study_id>2014/009/HP</org_study_id>
    <nct_id>NCT03257319</nct_id>
  </id_info>
  <brief_title>Inhaled vs IV Opioid Dosing for the Initial Treatment of Severe Acute Pain in the Emergency Department</brief_title>
  <acronym>CLIN-AEROMORPH</acronym>
  <official_title>Inhaled Versus Intravenous Opioid Dosing for the Initial Treatment of Severe Acute Pain in the Emergency Department</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Rouen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Rouen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective single-blind, multicenter, national, randomized, controlled trial in 15 Emergency&#xD;
      Department to compare two ways of morphine titration. The eligible patient is included&#xD;
      immediately after his arrival in the Emergency Department, after being questioned by the&#xD;
      triage nurse about the presence and the intensity of pain, when the VAS is greater than 70&#xD;
      (or EN&gt;7) and after written consent.&#xD;
&#xD;
      After installation into the examination room, patient is randomized in one of two parallel&#xD;
      groups (stratified by sex and center using software) and receives one of the two treatments,&#xD;
      either inhaled morphine + IV placebo or IV morphine+ inhaled placebo (control group).&#xD;
&#xD;
      In both groups, titration is defined by a dose of repeated boluses as long as the relief is&#xD;
      not achieved (VAS&gt; 30 or EN &gt;3) and the criteria to stop titration are not met.&#xD;
&#xD;
      A 5 minutes time interval between the boluses is chosen. Each aerosol takes 5 minutes at a&#xD;
      constant air flow, aerosol mask, plastic tubing and PVC transparent tank are used.&#xD;
&#xD;
      Thus patient receives a maximum of 3 aerosol (one aerosol every 10 minutes) and a maximum of&#xD;
      6 IV injections (one injection every 5 minutes) The stopping criteria, except pain relief,&#xD;
      are linked to the occurrence of side effects and specific cares are described into the&#xD;
      protocol (in case of severe ventilatory depression naloxone titration is provided). Exit&#xD;
      criteria from the emergency room and from the hospital are defined. An information sheet is&#xD;
      delivered.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 19, 2017</start_date>
  <completion_date type="Anticipated">September 19, 2019</completion_date>
  <primary_completion_date type="Anticipated">September 19, 2019</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of relief obtained or &quot;success rate&quot; at 1 hour from the start of drug administration, and not at the end of titration, such as EVA1 ≤ 30/100 (or EN1 ≤ 3/10).</measure>
    <time_frame>1 hour after the initiation of the titration</time_frame>
    <description>Rate of relief obtained or &quot;success rate&quot; at 1 hour from the start of drug administration, and not at the end of titration, such as EVA1 ≤ 30/100 (or EN1 ≤ 3/10).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluate antalgic efficacy criteria</measure>
    <time_frame>From the beginning of the titration until the end of the titration- assessed within one day</time_frame>
    <description>Quantity of morphine administered from the beginning of the titration until the end of the titration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate antalgic efficacy criteria</measure>
    <time_frame>From the beginning of the titration until the end of the titration- assessed up to one day</time_frame>
    <description>Delay between first administration of Morphine and EVA ≤ 30 or EN ≤ 3 obtained</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate antalgic efficacy criteria</measure>
    <time_frame>From the beginning of the titration until the end of the titration- assessed up to one day</time_frame>
    <description>Delay between first administration of Morphine and EVA ≤ 30 or EN ≤ 3 obtained for patient treated only with morphine IV</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate antalgic efficacy criteria</measure>
    <time_frame>From the beginning of the titration until the end of the titration- assessed up to one day</time_frame>
    <description>Number of patients with EVA ≤ 30 or EN ≤ 3 at the end of titration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate antalgic efficacy criteria</measure>
    <time_frame>30 minutes after the initiation of the titration</time_frame>
    <description>Number of patients with EVA ≤ 30 or EN ≤ 3 at 30 minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate antalgic efficacy criteria</measure>
    <time_frame>From the beginning of the titration until the end of the titration- assessed up to one day</time_frame>
    <description>Number of patients treated only by exclusive inhalation titration with EVA ≤ 30 or EN ≤ 3</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate antalgic efficacy criteria</measure>
    <time_frame>From the beginning of the titration until the end of the titration- assessed up to one day</time_frame>
    <description>Quantity of of co-analgesia administered from the beginning of the titration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate antalgic efficacy criteria</measure>
    <time_frame>1hour after the initiation of the titration</time_frame>
    <description>Number of patients with EVA ≤ 30 or EN ≤ 3 after 60 minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate antalgic efficacy criteria</measure>
    <time_frame>2hours after the initiation of the titration</time_frame>
    <description>Number of patients with EVA ≤ 30 or EN ≤ 3 after 120 minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess the feasibility of an aerosol titration (compliance to the protocol)</measure>
    <time_frame>From the beginning of the titration until the end of the aerosol titration- within one hour after the start of the titration</time_frame>
    <description>Number of deviations from protocol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety-Proportion of Sleepy patients (Ramsay score = 3) (adverse events)</measure>
    <time_frame>Until 3hours after the end of the titration</time_frame>
    <description>Proportion of Sleepy patients (Ramsay score = 3)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety- incidence of minor side effects in each arm of which neurovegetative usually known and related to opiates (nausea, vomiting, urine retention, ...)</measure>
    <time_frame>Until 3hours after the end of the titration</time_frame>
    <description>incidence of minor side effects in each arm of which neurovegetative usually known and related to opiates (nausea, vomiting, urine retention,&#xD;
...)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety- Proportion of serious adverse events in each arm</measure>
    <time_frame>Until 3hours after the end of the titration</time_frame>
    <description>Proportion of serious adverse events in each arm</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">850</enrollment>
  <condition>Pain, Acute</condition>
  <condition>Emergencies</condition>
  <condition>Morphine</condition>
  <arm_group>
    <arm_group_label>inhaled morphine + IV placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arm A: inhaled titration of morphine chlorhydrate+ IV placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IV morphine +inhaled placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Arm B:IV titration of morphine chlorhydrate + inhaled placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>inhaled titration of morphine chlorhydrate</intervention_name>
    <description>Patient in arm A will receive 1 to 3 titration</description>
    <arm_group_label>inhaled morphine + IV placebo</arm_group_label>
    <other_name>IV placebo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IV placebo</intervention_name>
    <description>Patient in arm A will receive 1 to 6 injection</description>
    <arm_group_label>inhaled morphine + IV placebo</arm_group_label>
    <other_name>inhaled titration of morphine chlorhydrate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Inhaled placebo</intervention_name>
    <description>Patient in arm B will receive 1 to 3 titration</description>
    <arm_group_label>IV morphine +inhaled placebo</arm_group_label>
    <other_name>IV titration of morphine chlorhydrate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IV titration of morphine chlorhydrate</intervention_name>
    <description>Patient in arm BA will receive 1 to 6 injection</description>
    <arm_group_label>IV morphine +inhaled placebo</arm_group_label>
    <other_name>Inhaled placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 and &lt;75 years old;&#xD;
&#xD;
          -  EVA ≥ 70/100 or EN ≥ 7/10;&#xD;
&#xD;
          -  Patient who received clear information from the investigator and read and signed the&#xD;
             consent form;&#xD;
&#xD;
          -  Patient affiliated with, or beneficiary of a social security category;&#xD;
&#xD;
          -  For women:&#xD;
&#xD;
        O of childbearing age: effective contraception (oral contraception, intrauterine device or&#xD;
        use of condoms) O menopausal status (amenorrhoea less than 12 months before the inclusion&#xD;
        visit) O objectivized sterility (diagnosis or surgically)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic pain (&gt; 3 months)&#xD;
&#xD;
          -  Taking opioids longer than 10 days (including &quot;weak&quot; opioids tramadol and / or&#xD;
             codeine);&#xD;
&#xD;
          -  Taking Rifampicin;&#xD;
&#xD;
          -  Impaired ability to discern, cognitive impairment;&#xD;
&#xD;
          -  Morphine-related contraindications:&#xD;
&#xD;
        O Obstructive chronic obstructive or restrictive respiratory failure known or suspected&#xD;
        compensated or not, O Hypersensitivity to the active substance or to any of the excipients,&#xD;
        O Severe hepatocellular insufficiency (known or suspected), O Chronic renal failure known&#xD;
        or suspected, O Uncontrolled epilepsy, O Cranial trauma (intracranial hypertension), O&#xD;
        Associations with buprenorphine, nalbuphine, pentazocine and naltrexone&#xD;
&#xD;
          -  Active drug history or practice (s);&#xD;
&#xD;
          -  Evidence of reduced fracture or dislocation in emergency rooms;&#xD;
&#xD;
          -  Suspected occlusive syndrome&#xD;
&#xD;
          -  SaO2 &lt;95%;&#xD;
&#xD;
          -  FR &lt;12 / min;&#xD;
&#xD;
          -  Glasgow &lt;15 or other alertness disorders;&#xD;
&#xD;
          -  HR heart rate &lt;50 bpm and / or Auriculo-Ventricular block (PR XML File Identifier:&#xD;
             zR6XOYKSEQ9GjQHghP8c465EwF0= Page 15/30 interval&gt; 200 ms);&#xD;
&#xD;
          -  Arterial hypotension with systolic blood pressure TA syst &lt;100 mm Hg;&#xD;
&#xD;
          -  Pregnant or nursing&#xD;
&#xD;
          -  Persons deprived of their liberty by an administrative or judicial decision, a person&#xD;
             placed under the safeguard of justice, guardianship;&#xD;
&#xD;
          -  Patients with poor comprehension of spoken or written French;&#xD;
&#xD;
          -  Patients participating in another interventional clinical study;&#xD;
&#xD;
          -  Contra-indication related to the use of saline solution&#xD;
&#xD;
          -  Contra-indications related to the use of aerosol:&#xD;
&#xD;
        O Necessity to access the face O Allergy known to plastic&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CH Agen-Nérac</name>
      <address>
        <city>Agen</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>P-A FORT</last_name>
      <phone>05 53 69 70 93</phone>
      <email>pierrearnaudf@yahoo.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHI Robert Ballanger</name>
      <address>
        <city>Aulnay-sous-Bois</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anna BOUCHARA</last_name>
      <phone>01 49 36 72 12</phone>
      <phone_ext>+33</phone_ext>
      <email>anna.bouchara@ch-aulnay.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU Hôpitaux BORDEAUX</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>M GALINSKI</last_name>
      <phone>05 56 79 48 26</phone>
      <email>michel.galinski@chu-bordeaux.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Caen</name>
      <address>
        <city>Caen</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>C LE ROUX</last_name>
      <phone>02 31 06 52 40</phone>
      <email>leroux-c@chu-caen.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU Gabriel Montpied</name>
      <address>
        <city>Clermont-Ferrand</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>J. RACONNAT</last_name>
      <phone>04 73 75 07 50</phone>
      <email>jraconnat@chu-clermontferrand.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU Grenoble</name>
      <address>
        <city>Grenoble</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>M MAIGNAN</last_name>
      <phone>04 76 76 59 31</phone>
      <email>mmaignan@chu-grenoble.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>GH Le Havre</name>
      <address>
        <city>Le Havre</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>XAVIER BENET</last_name>
      <phone>02 32 73 32 32</phone>
      <email>xav.benet@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CH Le Mans</name>
      <address>
        <city>Le Mans</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>O MOULIN</last_name>
      <phone>02 43 43 43 43</phone>
      <email>omoulin@ch-lemans.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHRU de Lille</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>eric wiel</last_name>
      <phone>03 20 44 59 62</phone>
      <email>eric.wiel@chru-lille.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospices civils de Lyon</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>karim tazarourte</last_name>
      <phone>04 72 11 00 31</phone>
      <email>karim.tazarourte@chu-lyon.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU Nice</name>
      <address>
        <city>Nice</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>J LEVRAUT</last_name>
      <phone>04 92 03 77 77</phone>
      <email>levraut.j@chu-nice.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hopital COCHIN</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>F LECOMTE</last_name>
      <phone>04 58 41 41 41</phone>
      <email>francois.lecomte@aphp.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital Lariboisière</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>N Ouled-Jaballah</last_name>
      <phone>01 49 95 63 91</phone>
      <email>nora.ouled@aphp.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>La Pitié Salpétrière</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>pierre Hausfater</last_name>
      <phone>01 42 17 72 40</phone>
      <email>pierre.hausfater@psl.aphp.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU-Hôpitaux de Rouen</name>
      <address>
        <city>Rouen</city>
        <zip>76031</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lionel DA CRUZ</last_name>
      <phone>0232888265</phone>
      <phone_ext>+33</phone_ext>
      <email>secretariat.drc@chu-rouen.fr</email>
    </contact>
    <contact_backup>
      <last_name>Cécile POURCHER</last_name>
      <phone>0232888265</phone>
      <phone_ext>+33</phone_ext>
      <email>secretariat.drc@chu-rouen.fr</email>
    </contact_backup>
    <investigator>
      <last_name>Virginie-Eve LVOVSCHI</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Bichat-Claude Bernard</name>
      <address>
        <city>Saint-Ouen</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>A-E CASALINO</last_name>
      <phone>1 40 25 77 60</phone>
      <phone_ext>+33</phone_ext>
      <email>enrique.casalino@bch.aphp.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Chu Strasbourg</name>
      <address>
        <city>Strasbourg</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>S kepka</last_name>
      <phone>03 69 55 13 35</phone>
      <email>sabrinakepka@yahoo.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>chu de Toulouse</name>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>S charpentier</last_name>
      <phone>0561323354</phone>
      <email>charpentier.s@chu-toulouse.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CH Eure Seine Hôpital d'Evreux</name>
      <address>
        <city>Évreux</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Arnaud Depil-duva</last_name>
      <phone>02 32 33 85 10</phone>
      <email>arnaud.depil-duval@ch-eureseine.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>July 20, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>May 25, 2018</last_update_submitted>
  <last_update_submitted_qc>May 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
    <mesh_term>Acute Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Morphine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03257319
org study id: 2014/009/HP
nct id: NCT03257319
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prospective single-blind, multicenter, national, randomized, controlled trial in 15 Emergency
      Department to compare two ways of morphine titration. The eligible patient is included
      immediately after his arrival in the Emergency Department, after being questioned by the
      triage nurse about the presence and the intensity of pain, when the VAS is greater than 70
      (or EN>7) and after written consent.

      After installation into the examination room, patient is randomized in one of two parallel
      groups (stratified by sex and center using software) and receives one of the two treatments,
      either inhaled morphine + IV placebo or IV morphine+ inhaled placebo (control group).

      In both groups, titration is defined by a dose of repeated boluses as long as the relief is
      not achieved (VAS> 30 or EN >3) and the criteria to stop titration are not met.

      A 5 minutes time interval between the boluses is chosen. Each aerosol takes 5 minutes at a
      constant air flow, aerosol mask, plastic tubing and PVC transparent tank are used.

      Thus patient receives a maximum of 3 aerosol (one aerosol every 10 minutes) and a maximum of
      6 IV injections (one injection every 5 minutes) The stopping criteria, except pain relief,
      are linked to the occurrence of side effects and specific cares are described into the
      protocol (in case of severe ventilatory depression naloxone titration is provided). Exit
      criteria from the emergency room and from the hospital are defined. An information sheet is
      delivered.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Rate of relief obtained or "success rate" at 1 hour from the start of drug administration, and not at the end of titration, such as EVA1 ≤ 30/100 (or EN1 ≤ 3/10).
time frame: 1 hour after the initiation of the titration
description: Rate of relief obtained or "success rate" at 1 hour from the start of drug administration, and not at the end of titration, such as EVA1 ≤ 30/100 (or EN1 ≤ 3/10).
measure: Evaluate antalgic efficacy criteria
time frame: From the beginning of the titration until the end of the titration- assessed within one day
description: Quantity of morphine administered from the beginning of the titration until the end of the titration
measure: Evaluate antalgic efficacy criteria
time frame: From the beginning of the titration until the end of the titration- assessed up to one day
description: Delay between first administration of Morphine and EVA ≤ 30 or EN ≤ 3 obtained
measure: Evaluate antalgic efficacy criteria
time frame: From the beginning of the titration until the end of the titration- assessed up to one day
description: Delay between first administration of Morphine and EVA ≤ 30 or EN ≤ 3 obtained for patient treated only with morphine IV
measure: Evaluate antalgic efficacy criteria
time frame: From the beginning of the titration until the end of the titration- assessed up to one day
description: Number of patients with EVA ≤ 30 or EN ≤ 3 at the end of titration
measure: Evaluate antalgic efficacy criteria
time frame: 30 minutes after the initiation of the titration
description: Number of patients with EVA ≤ 30 or EN ≤ 3 at 30 minutes
measure: Evaluate antalgic efficacy criteria
time frame: From the beginning of the titration until the end of the titration- assessed up to one day
description: Number of patients treated only by exclusive inhalation titration with EVA ≤ 30 or EN ≤ 3
measure: Evaluate antalgic efficacy criteria
time frame: From the beginning of the titration until the end of the titration- assessed up to one day
description: Quantity of of co-analgesia administered from the beginning of the titration
measure: Evaluate antalgic efficacy criteria
time frame: 1hour after the initiation of the titration
description: Number of patients with EVA ≤ 30 or EN ≤ 3 after 60 minutes
measure: Evaluate antalgic efficacy criteria
time frame: 2hours after the initiation of the titration
description: Number of patients with EVA ≤ 30 or EN ≤ 3 after 120 minutes
measure: Assess the feasibility of an aerosol titration (compliance to the protocol)
time frame: From the beginning of the titration until the end of the aerosol titration- within one hour after the start of the titration
description: Number of deviations from protocol
measure: Safety-Proportion of Sleepy patients (Ramsay score = 3) (adverse events)
time frame: Until 3hours after the end of the titration
description: Proportion of Sleepy patients (Ramsay score = 3)
measure: Safety- incidence of minor side effects in each arm of which neurovegetative usually known and related to opiates (nausea, vomiting, urine retention, ...)
time frame: Until 3hours after the end of the titration
description: incidence of minor side effects in each arm of which neurovegetative usually known and related to opiates (nausea, vomiting, urine retention,
...)
measure: Safety- Proportion of serious adverse events in each arm
time frame: Until 3hours after the end of the titration
description: Proportion of serious adverse events in each arm
arm group label: inhaled morphine + IV placebo
arm group type: Experimental
description: Arm A: inhaled titration of morphine chlorhydrate+ IV placebo
arm group label: IV morphine +inhaled placebo
arm group type: Placebo Comparator
description: Arm B:IV titration of morphine chlorhydrate + inhaled placebo
intervention type: Drug
intervention name: inhaled titration of morphine chlorhydrate
description: Patient in arm A will receive 1 to 3 titration
arm group label: inhaled morphine + IV placebo
other name: IV placebo
intervention type: Drug
intervention name: IV placebo
description: Patient in arm A will receive 1 to 6 injection
arm group label: inhaled morphine + IV placebo
other name: inhaled titration of morphine chlorhydrate
intervention type: Device
intervention name: Inhaled placebo
description: Patient in arm B will receive 1 to 3 titration
arm group label: IV morphine +inhaled placebo
other name: IV titration of morphine chlorhydrate
intervention type: Drug
intervention name: IV titration of morphine chlorhydrate
description: Patient in arm BA will receive 1 to 6 injection
arm group label: IV morphine +inhaled placebo
other name: Inhaled placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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contact backup: 
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facility: 
status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Emergencies
mesh term: Acute Pain
mesh term: Morphine
sharing ipd: No