<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/NCT02198378</url>
  </required_header>
  <id_info>
    <org_study_id>RC31/13/7050</org_study_id>
    <secondary_id>13705001</secondary_id>
    <nct_id>NCT02198378</nct_id>
  </id_info>
  <brief_title>Comparison of MEOPA + Paracetamol Versus Morphine Treatment in Acute Coronary Syndrome Analgesia.</brief_title>
  <acronym>SCADOLII</acronym>
  <official_title>Analgesia of Acute Coronary Syndromes With ST-segment Elevation in a Pre-hospital Setting. Randomized Non-inferiority Trial of the Association MEOPA + Paracetamol Versus Morphine.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Toulouse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Toulouse</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In the management of acute coronary syndromes with ST-segment elevation (STEMI), early&#xD;
      analgesia reduces the effects of hyperadrenalism which increases the size of myocardial&#xD;
      infarction. In order to reduce pain intensity, the recommendations advocate emergency use of&#xD;
      morphine. In STEMI patients, other analgesic treatments could provide analgesia that is at&#xD;
      least as effective as morphine. The equimolar oxygen/nitrous oxide mixture (MEOPA) is widely&#xD;
      used in emergency medicine and has minor secondary effects that are very rapidly reversible&#xD;
      when inhalation is discontinued. Used in association with paracetamol, it could be an at&#xD;
      least equally effective alternative to the use of morphine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators wish to compare the use of morphine according to current recommendations&#xD;
      with the use of MEOPA associated with intravenous paracetamol in the management of patients&#xD;
      with STEMI. The investigators hypothesize that the association of MEOPA and paracetamol,&#xD;
      which is easy to use in a pre-hospital setting, will give patients pain relief as effectively&#xD;
      as morphine.&#xD;
&#xD;
      This alternative treatment would avoid the use of morphine, whose potentially damaging&#xD;
      consequences on myocardial function have been suggested by experimental studies and by an&#xD;
      observational study. The physician of the mobile emergency team (SMUR) verifies the inclusion&#xD;
      and non- inclusion criteria for the study. The patient must present STEMI defined in&#xD;
      accordance with the recommendations and chest pain of intensity ≥ 4 on the NRS. The specific&#xD;
      treatment for STEMI will be given before inclusion in the study, with the exception of&#xD;
      analgesic treatment. In particular, inclusion in the study must not delay the initiation of&#xD;
      strategies of recanalization and reperfusion.&#xD;
&#xD;
      The SMUR physician in charge of the patient will administer the treatment defined by&#xD;
      randomization.&#xD;
&#xD;
      After 30 minutes, the patient will be managed in accordance with the recommendations and will&#xD;
      be hospitalized, generally in a cardiology intensive care unit. At one month, the clinical&#xD;
      research technician will record the patient's vital status and collect the patient's hospital&#xD;
      records.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2014</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">January 2017</primary_completion_date>
  <phase>Phase 4</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effective analgesia (NRS score≤ 3) at 30 minutes after the start of analgesia</measure>
    <time_frame>30 minutes after randomisation.</time_frame>
    <description>The primary outcome measure is effective analgesia, defined by the consensus conference as an NRS score ≤ 3 at 30 minutes after the start of analgesia.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse event</measure>
    <time_frame>all 5 minutes during 30 minutes</time_frame>
    <description>Occurrence of an adverse effect, in particular, respiratory depression (RR, respiratory rate &lt; 10 cycles par minute or respiratory score ≥ R1), nausea, vomiting, sedation (sedation scale (EDS) score ≥2), dizziness, pruritus.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NRS distribution</measure>
    <time_frame>30 minutes after randomization</time_frame>
    <description>Distribution of the NRS at 30 minutes and on arrival at the cardiology unit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effective analgesia</measure>
    <time_frame>all 5 minutes during 30 minutes</time_frame>
    <description>The time of effective analgesia will be defined for each subject</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">680</enrollment>
  <condition>Acute Coronary Syndrome</condition>
  <arm_group>
    <arm_group_label>Morphine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Morphine group: administration of morphine will start with a 0.05 mg/kg bolus followed by reinjection of 2 mg every 5 minutes until effective analgesia is obtained, defined as NRS ≤ 3.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MEOPA and paracetamol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patient will be equipped with a facemask delivering MEOPA.The gas flow received by the patient is adapted to his/her ventilation.&#xD;
During the same time, an intravenous injection of 1 g paracetamol will be administered.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MEOPA and paracetamol</intervention_name>
    <description>The patient will be equipped with a facemask after he/she has been informed. The facemask is adapted to the patient. The patient breathes normally in the mask which is held in place by a member of the SMUR team who has received previous training in use of MEOPA. The gas flow received by the patient is adapted to his/her ventilation.</description>
    <arm_group_label>MEOPA and paracetamol</arm_group_label>
    <other_name>Entonox 170 bar</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Morphine</intervention_name>
    <description>Bolus of 2 mg intravenously if EN = 4 or 5 and 3 mg bolus if EN&gt; 6 followed by reinjection of 2mg every 5 minutes until effective analgesia.</description>
    <arm_group_label>Morphine</arm_group_label>
    <other_name>Morphine Renaudin 1mg/ml</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with STEMI &lt; 12 h treated before hospital admission and pain ≥ 4 on the&#xD;
             numerical rating scale.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute severe hemodynamic, respiratory or neurological failure&#xD;
&#xD;
          -  Heart failure: Killip class III and IV&#xD;
&#xD;
          -  Known allergy to morphine or nitrous oxide&#xD;
&#xD;
          -  Patient who has already received morphine or MEOPA before the arrival of the hospital&#xD;
             team during the 4 hours preceding the pre-hospital intervention&#xD;
&#xD;
          -  Contraindications to nitrous oxide&#xD;
&#xD;
          -  Patient unable to assess pain intensity on the numerical rating scale&#xD;
&#xD;
          -  Patient under legal guardianship&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Patient transported by air ambulance&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sandrine Charpentier, PH,MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Toulouse</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Hospitalier d'Agen</name>
      <address>
        <city>Agen</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Jean Minjoz</name>
      <address>
        <city>Besançon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Avicenne</name>
      <address>
        <city>Bobigny</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Pellegrin</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Bourg-en-Bresse</name>
      <address>
        <city>Bourg-en-Bresse</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Chambéry</name>
      <address>
        <city>Chambéry</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Louis Pasteur</name>
      <address>
        <city>Chartres</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Chateauroux</name>
      <address>
        <city>Chateauroux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU d'Estaing</name>
      <address>
        <city>Clermont-Ferrand</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Beaujon</name>
      <address>
        <city>Clichy</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Alpes Léman</name>
      <address>
        <city>Contamine sur Arve</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Sud Francilien</name>
      <address>
        <city>Corbeil-Essonnes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Dijon</name>
      <address>
        <city>Dijon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier du Val d'Ariège</name>
      <address>
        <city>Foix</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Raymond Poincaré</name>
      <address>
        <city>Garches</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Grenoble</name>
      <address>
        <city>Grenoble</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Départemental La Roche/Yon</name>
      <address>
        <city>La Roche-sur-Yon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU Lille</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Dupuytren</name>
      <address>
        <city>Limoges</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Edouard Herriot</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de la Timone</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Marc Jacquet</name>
      <address>
        <city>Melun</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHR Bon Secours</name>
      <address>
        <city>Metz</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU Montpellier</name>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Nancy</name>
      <address>
        <city>Nancy</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Nantes</name>
      <address>
        <city>Nantes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Nice</name>
      <address>
        <city>Nice</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Necker</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Pitié-Salpétrière</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Groupe hospitamier Lariboisière-Fernand Widal-St-Louis</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Poitiers</name>
      <address>
        <city>Poitiers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier René Dubos</name>
      <address>
        <city>Pontoise</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Annecy-Gennevois</name>
      <address>
        <city>Pringy</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Comminges Pyrénées</name>
      <address>
        <city>Saint-Gaudens</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Poulon la Seyne-sur-mer</name>
      <address>
        <city>Toulon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Toulouse</name>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU Tours</name>
      <address>
        <city>Tours</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Valence</name>
      <address>
        <city>Valence</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Lucien Hussel</name>
      <address>
        <city>Vienne</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Félix Guyon</name>
      <address>
        <city>Saint-Denis</city>
        <country>Réunion</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Réunion</country>
  </location_countries>
  <reference>
    <citation>Danchin N, Puymirat E, Aissaoui N, Adavane S, Durand E. [Epidemiology of acute coronary syndromes in France and in Europe]. Ann Cardiol Angeiol (Paris). 2010 Dec;59 Suppl 2:S37-41. doi: 10.1016/S0003-3928(10)70008-1. French.</citation>
    <PMID>21237321</PMID>
  </reference>
  <reference>
    <citation>Myocardial infarction redefined--a consensus document of The Joint European Society of Cardiology/American College of Cardiology Committee for the redefinition of myocardial infarction. Eur Heart J. 2000 Sep;21(18):1502-13. doi: 10.1053/euhj.2000.2305.</citation>
    <PMID>10973764</PMID>
  </reference>
  <reference>
    <citation>Task Force for Diagnosis and Treatment of Non-ST-Segment Elevation Acute Coronary Syndromes of European Society of Cardiology; Bassand JP, Hamm CW, Ardissino D, Boersma E, Budaj A, Fernandez-Aviles F, Fox KA, Hasdai D, Ohman EM, Wallentin L, Wijns W. Guidelines for the diagnosis and treatment of non-ST-segment elevation acute coronary syndromes. Eur Heart J. 2007 Jul;28(13):1598-660. doi: 10.1093/eurheartj/ehm161. Epub 2007 Jun 14. No abstract available.</citation>
    <PMID>17569677</PMID>
  </reference>
  <reference>
    <citation>Van de Werf F, Bax J, Betriu A, Blomstrom-Lundqvist C, Crea F, Falk V, Filippatos G, Fox K, Huber K, Kastrati A, Rosengren A, Steg PG, Tubaro M, Verheugt F, Weidinger F, Weis M; ESC Committee for Practice Guidelines (CPG). Management of acute myocardial infarction in patients presenting with persistent ST-segment elevation: the Task Force on the Management of ST-Segment Elevation Acute Myocardial Infarction of the European Society of Cardiology. Eur Heart J. 2008 Dec;29(23):2909-45. doi: 10.1093/eurheartj/ehn416. Epub 2008 Nov 12. No abstract available.</citation>
    <PMID>19004841</PMID>
  </reference>
  <reference>
    <citation>Canadian Cardiovascular Society; American Academy of Family Physicians; American College of Cardiology; American Heart Association; Antman EM, Hand M, Armstrong PW, Bates ER, Green LA, Halasyamani LK, Hochman JS, Krumholz HM, Lamas GA, Mullany CJ, Pearle DL, Sloan MA, Smith SC Jr, Anbe DT, Kushner FG, Ornato JP, Pearle DL, Sloan MA, Jacobs AK, Adams CD, Anderson JL, Buller CE, Creager MA, Ettinger SM, Halperin JL, Hunt SA, Lytle BW, Nishimura R, Page RL, Riegel B, Tarkington LG, Yancy CW. 2007 focused update of the ACC/AHA 2004 guidelines for the management of patients with ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2008 Jan 15;51(2):210-47. doi: 10.1016/j.jacc.2007.10.001. No abstract available. Erratum In: J Am Coll Cardiol. 2008 Mar 4;51(9):977.</citation>
    <PMID>18191746</PMID>
  </reference>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>July 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <last_update_submitted>February 2, 2018</last_update_submitted>
  <last_update_submitted_qc>February 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>premixed nitrous oxide and oxygen</keyword>
  <keyword>pain</keyword>
  <keyword>prehospital setting</keyword>
  <keyword>acute coronary syndrome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetaminophen</mesh_term>
    <mesh_term>Morphine</mesh_term>
    <mesh_term>Entonox</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02198378
org study id: RC31/13/7050
secondary id: 13705001
nct id: NCT02198378
lead sponsor: 
has dmc: No
In the management of acute coronary syndromes with ST-segment elevation (STEMI), early
      analgesia reduces the effects of hyperadrenalism which increases the size of myocardial
      infarction. In order to reduce pain intensity, the recommendations advocate emergency use of
      morphine. In STEMI patients, other analgesic treatments could provide analgesia that is at
      least as effective as morphine. The equimolar oxygen/nitrous oxide mixture (MEOPA) is widely
      used in emergency medicine and has minor secondary effects that are very rapidly reversible
      when inhalation is discontinued. Used in association with paracetamol, it could be an at
      least equally effective alternative to the use of morphine.
The investigators wish to compare the use of morphine according to current recommendations
      with the use of MEOPA associated with intravenous paracetamol in the management of patients
      with STEMI. The investigators hypothesize that the association of MEOPA and paracetamol,
      which is easy to use in a pre-hospital setting, will give patients pain relief as effectively
      as morphine.

      This alternative treatment would avoid the use of morphine, whose potentially damaging
      consequences on myocardial function have been suggested by experimental studies and by an
      observational study. The physician of the mobile emergency team (SMUR) verifies the inclusion
      and non- inclusion criteria for the study. The patient must present STEMI defined in
      accordance with the recommendations and chest pain of intensity ≥ 4 on the NRS. The specific
      treatment for STEMI will be given before inclusion in the study, with the exception of
      analgesic treatment. In particular, inclusion in the study must not delay the initiation of
      strategies of recanalization and reperfusion.

      The SMUR physician in charge of the patient will administer the treatment defined by
      randomization.

      After 30 minutes, the patient will be managed in accordance with the recommendations and will
      be hospitalized, generally in a cardiology intensive care unit. At one month, the clinical
      research technician will record the patient's vital status and collect the patient's hospital
      records.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Effective analgesia (NRS score≤ 3) at 30 minutes after the start of analgesia
time frame: 30 minutes after randomisation.
description: The primary outcome measure is effective analgesia, defined by the consensus conference as an NRS score ≤ 3 at 30 minutes after the start of analgesia.
measure: Adverse event
time frame: all 5 minutes during 30 minutes
description: Occurrence of an adverse effect, in particular, respiratory depression (RR, respiratory rate < 10 cycles par minute or respiratory score ≥ R1), nausea, vomiting, sedation (sedation scale (EDS) score ≥2), dizziness, pruritus.
measure: NRS distribution
time frame: 30 minutes after randomization
description: Distribution of the NRS at 30 minutes and on arrival at the cardiology unit
measure: Effective analgesia
time frame: all 5 minutes during 30 minutes
description: The time of effective analgesia will be defined for each subject
arm group label: Morphine
arm group type: Active Comparator
description: Morphine group: administration of morphine will start with a 0.05 mg/kg bolus followed by reinjection of 2 mg every 5 minutes until effective analgesia is obtained, defined as NRS ≤ 3.
arm group label: MEOPA and paracetamol
arm group type: Experimental
description: The patient will be equipped with a facemask delivering MEOPA.The gas flow received by the patient is adapted to his/her ventilation.
During the same time, an intravenous injection of 1 g paracetamol will be administered.
intervention type: Drug
intervention name: MEOPA and paracetamol
description: The patient will be equipped with a facemask after he/she has been informed. The facemask is adapted to the patient. The patient breathes normally in the mask which is held in place by a member of the SMUR team who has received previous training in use of MEOPA. The gas flow received by the patient is adapted to his/her ventilation.
arm group label: MEOPA and paracetamol
other name: Entonox 170 bar
intervention type: Drug
intervention name: Morphine
description: Bolus of 2 mg intravenously if EN = 4 or 5 and 3 mg bolus if EN> 6 followed by reinjection of 2mg every 5 minutes until effective analgesia.
arm group label: Morphine
other name: Morphine Renaudin 1mg/ml
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sandrine Charpentier, PH,MD
role: Principal Investigator
affiliation: CHU Toulouse
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country: France
country: Réunion
citation: Danchin N, Puymirat E, Aissaoui N, Adavane S, Durand E. [Epidemiology of acute coronary syndromes in France and in Europe]. Ann Cardiol Angeiol (Paris). 2010 Dec;59 Suppl 2:S37-41. doi: 10.1016/S0003-3928(10)70008-1. French.
PMID: 21237321
citation: Myocardial infarction redefined--a consensus document of The Joint European Society of Cardiology/American College of Cardiology Committee for the redefinition of myocardial infarction. Eur Heart J. 2000 Sep;21(18):1502-13. doi: 10.1053/euhj.2000.2305.
PMID: 10973764
citation: Task Force for Diagnosis and Treatment of Non-ST-Segment Elevation Acute Coronary Syndromes of European Society of Cardiology; Bassand JP, Hamm CW, Ardissino D, Boersma E, Budaj A, Fernandez-Aviles F, Fox KA, Hasdai D, Ohman EM, Wallentin L, Wijns W. Guidelines for the diagnosis and treatment of non-ST-segment elevation acute coronary syndromes. Eur Heart J. 2007 Jul;28(13):1598-660. doi: 10.1093/eurheartj/ehm161. Epub 2007 Jun 14. No abstract available.
PMID: 17569677
citation: Van de Werf F, Bax J, Betriu A, Blomstrom-Lundqvist C, Crea F, Falk V, Filippatos G, Fox K, Huber K, Kastrati A, Rosengren A, Steg PG, Tubaro M, Verheugt F, Weidinger F, Weis M; ESC Committee for Practice Guidelines (CPG). Management of acute myocardial infarction in patients presenting with persistent ST-segment elevation: the Task Force on the Management of ST-Segment Elevation Acute Myocardial Infarction of the European Society of Cardiology. Eur Heart J. 2008 Dec;29(23):2909-45. doi: 10.1093/eurheartj/ehn416. Epub 2008 Nov 12. No abstract available.
PMID: 19004841
citation: Canadian Cardiovascular Society; American Academy of Family Physicians; American College of Cardiology; American Heart Association; Antman EM, Hand M, Armstrong PW, Bates ER, Green LA, Halasyamani LK, Hochman JS, Krumholz HM, Lamas GA, Mullany CJ, Pearle DL, Sloan MA, Smith SC Jr, Anbe DT, Kushner FG, Ornato JP, Pearle DL, Sloan MA, Jacobs AK, Adams CD, Anderson JL, Buller CE, Creager MA, Ettinger SM, Halperin JL, Hunt SA, Lytle BW, Nishimura R, Page RL, Riegel B, Tarkington LG, Yancy CW. 2007 focused update of the ACC/AHA 2004 guidelines for the management of patients with ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2008 Jan 15;51(2):210-47. doi: 10.1016/j.jacc.2007.10.001. No abstract available. Erratum In: J Am Coll Cardiol. 2008 Mar 4;51(9):977.
PMID: 18191746
responsible party type: Sponsor
mesh term: Acute Coronary Syndrome
mesh term: Syndrome
mesh term: Acetaminophen
mesh term: Morphine
mesh term: Entonox