<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/NCT02250729</url>
  </required_header>
  <id_info>
    <org_study_id>2012-A01735-38</org_study_id>
    <nct_id>NCT02250729</nct_id>
  </id_info>
  <brief_title>Allergy to Neuromuscular Blocking Agents and Pholcodine Exposure</brief_title>
  <acronym>ALPHO</acronym>
  <official_title>Anaphylaxis to Neuromuscular Blocking Agents and Pholcodine Exposure. Case-control Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central Hospital, Nancy, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Zambon SpA</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Laboratoires URGO</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>THE BOOTS COMPANY PLC</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pierre Fabre Medicament</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>LABORATOIRE HEPATOUM</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Biocodex</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sanofi</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Laboratoires Bouchara-Recordati</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>ALLIANCE PHARMACEUTICALS LIMITED</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>BELL SONS &amp; COMPANY</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>PINEWOOD LABORATORIES LIMITED</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>THORNTON &amp; ROSS &amp; Ross Ltd</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>ERNEST JACKSON &amp; Co. Ltd</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Central Hospital, Nancy, France</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main objective of this study is to compare pholcodine exposure in patients having&#xD;
      presented with a perianaesthetic anaphylactic reaction to a NMBA (cases) to pholcodine&#xD;
      exposure in matched anaesthetised patients with injection of NMBA, who did not present with&#xD;
      an anaphylactic reaction (controls).&#xD;
&#xD;
      The secondary objectives of the study are:&#xD;
&#xD;
        -  To compare anti-pholcodine IgE, anti-ammonium IV IgE and total IgE levels between the&#xD;
           case and control groups.&#xD;
&#xD;
        -  To study the concordance between exposure to pholcodine in cases and controls, by means&#xD;
           of a patient self-questionnaire on the one hand and, on the other hand, by a&#xD;
           computerized drug history, supplemented where relevant by the drug master file.&#xD;
&#xD;
        -  To study the impact of taking 1, 2 or 3 sources in account for pholcodine exposition.&#xD;
&#xD;
        -  To study the association between exposure to pholcodine and the presence/levels of&#xD;
           pholcodine-specific IgE, reflecting sensitisation to pholcodine.&#xD;
&#xD;
        -  To study NMBA and pholcodine cross-sensitisation by testing skin reactions to pholcodine&#xD;
           in case patients allergic to (at least) one NMBA.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 2014</start_date>
  <completion_date type="Anticipated">July 2020</completion_date>
  <primary_completion_date type="Anticipated">July 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Exposure to pholcodine</measure>
    <time_frame>within the 12 months before the anesthetic procedure</time_frame>
    <description>Exposure is measured by autoquestionnaire, patient's pharmaceutical file and drug history by the pharmacist's</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anti-pholcodine IgE, anti-ammonium IV IgE and total IgE levels between the case and control groups.</measure>
    <time_frame>Between 1 day to 12 weeks after the general anesthetic procedure</time_frame>
    <description>Cases: 6 to 12 weeks after the general anesthetic procedure (corresponding to the day of inclusion) Controls: during their hospitalisation after the general anesthetic procedure (Maximum 90 days after the general anesthetic procedure, corresponding to the day of inclusion)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concordance between exposure to pholcodine in cases and controls, by means of a patient self-questionnaire on the one hand and, on the other hand, by a computerized drug history, supplemented where relevant by the drug master file.</measure>
    <time_frame>within the 12 months preceeding the general anesthesia</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of non subjective sources in pholcodine exposure assessment</measure>
    <time_frame>within the 12 months preceeding general anesthetic procedure</time_frame>
    <description>We will study if pholcodine exposure criteria measured by autoquestionnaire is modified by taking into account non subjectives sources which are the patient's pharmaceutical file and his drug history by his pharmacist's</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between exposure to pholcodine and the presence/levels of pholcodine-specific IgE, reflecting sensitisation to pholcodine.</measure>
    <time_frame>within the 12 months preceding the general anesthetic procedure</time_frame>
    <description>IgE measurements: total IgE, IgE specific for pholcodine, quaternary ammoniums (KU/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NMBA and pholcodine cross-sensitisation by testing skin reactions to pholcodine in case patients allergic to one NMBA.</measure>
    <time_frame>6 to 12 weeks after the general anesthetic procedure</time_frame>
    <description>Only for Cases :&#xD;
Intradermal tests with diluted pholcodine. Intradermal tests with diluted NMBAs (as usual)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1020</enrollment>
  <condition>Neuromuscular Blocking Agents Anaphylaxis</condition>
  <arm_group>
    <arm_group_label>cases with NMBA anaphylaxis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who experienced NMBA anaphylaxis during anesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>controls</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients who underwent anesthesia with NMBA injection but did not experience anaphylaxis</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>intradermal pholcodine allergy test in cases</intervention_name>
    <arm_group_label>cases with NMBA anaphylaxis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood sampling</intervention_name>
    <arm_group_label>cases with NMBA anaphylaxis</arm_group_label>
    <arm_group_label>controls</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female, age ≥ 2 years old.&#xD;
&#xD;
          -  Referred to anaesthesia-allergy consultation within (approximately) 6 to 12 weeks of&#xD;
             occurrence of peranaesthetic anaphylactic reaction during anaesthesia with&#xD;
             administration of NMBAs (only for case patient).&#xD;
&#xD;
          -  Having given his/her consent (or the 2 parents consent for minors).&#xD;
&#xD;
          -  Affiliated with a social security scheme or dependent.&#xD;
&#xD;
          -  Able to answer a medicinal product intake questionnaire&#xD;
&#xD;
          -  In a clinical condition compatible with skin tests (no skin disease or psychiatric&#xD;
             illness, etc.) (only for case patient)&#xD;
&#xD;
          -  Having stopped any anti-histamine treatment at least 8 days previously (only for case&#xD;
             patient).&#xD;
&#xD;
          -  With positive skin test for the suspected NMBA (ony for case patient).&#xD;
&#xD;
          -  Patient anaesthetised in a control recruitment centre (only for control patients)&#xD;
&#xD;
          -  Having undergone anaesthesia with NMBA injection, without onset of peranaesthetic&#xD;
             anaphylactic reaction whatever his medical history (only for control patients)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have refused, or are unable to give their consent&#xD;
&#xD;
          -  Patients who have had negative control skin tests&#xD;
&#xD;
          -  Anaphylaxis suspected to be related to other drugs given on induction of anaesthesia,&#xD;
             eg. antibiotics&#xD;
&#xD;
          -  Having presented with anaphylactic reaction during a previous anaesthesia without NMBA&#xD;
             injection&#xD;
&#xD;
          -  Pregnant females at inclusion or during 12 months before anaesthesia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pierre GILLET, PU-PH MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU de Nancy</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Paul-Michel MERTES, PU-PH MD</last_name>
    <role>Study Director</role>
    <affiliation>CHU de Strasbourg</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Pierre Gillet, MD PhD</last_name>
    <email>pierre.gillet@univ.lorraine.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU d' ANGERS</name>
      <address>
        <city>Angers</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Martine DROUET, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Besançon</name>
      <address>
        <city>Besançon</city>
        <zip>25030</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Pascal GIRARDIN, MD</last_name>
      <email>pgirardin@chu-besancon.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Bordeaux</name>
      <address>
        <city>Bordeaux</city>
        <zip>33000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maryline Bordes</last_name>
      <email>maryline.bordes@chu-bordeaux.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Caen</name>
      <address>
        <city>Caen</city>
        <zip>14000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Delphine MARIOTTEFAUSSART, MD</last_name>
      <email>mariotte-d@chu-caen.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Clermont-Ferrand</name>
      <address>
        <city>Clermont- Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Omar OUTTAS, MD</last_name>
      <email>oouttas@chu-clermontferrand.fr;</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Dijon</name>
      <address>
        <city>Dijon</city>
        <zip>21033</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sandrine SELTZER, MD</last_name>
      <email>sandrine.seltzer@chu-dijon.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHRU de Lille</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>FACON Alain, MD</last_name>
      <email>alain.facon@chru-lille.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Limoges</name>
      <address>
        <city>Limoges</city>
        <zip>87042</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Isabelle ORSEL, MD</last_name>
      <email>isabelle.orsel@chu-limoges.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>AP-HM</name>
      <address>
        <city>Marseille</city>
        <zip>13915</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Marion GOUITAA-DETTORI, MD</last_name>
      <email>marion.gouitaa@ap-hm.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de MONTPELLIER</name>
      <address>
        <city>Montpellier</city>
        <zip>34000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pascal DEMOLY, Pr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHRU de Nancy</name>
      <address>
        <city>Nancy</city>
        <zip>54000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gérard AUDIBERT, MD-PHD</last_name>
      <email>g.audibert@chu-nancy.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de NANTES</name>
      <address>
        <city>Nantes</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>ANAIS PIPET, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Nice</name>
      <address>
        <city>Nice</city>
        <zip>06000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sylvie LEROY, MD</last_name>
      <email>leroy.s2@chu-nice.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fondation Hôpital St Joseph</name>
      <address>
        <city>Paris</city>
        <zip>75007</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marie-Laure MEGRET-GABEAUD, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>AP-HP- Hôpital Bichat</name>
      <address>
        <city>Paris</city>
        <zip>75877</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dan LONGROIS, MD- PHD</last_name>
      <email>dan.longrois@bch.aphp.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>AP-HP Paris TENON</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>ANGELE SORIA, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospices Civils de Lyon</name>
      <address>
        <city>Pierre-Bénite</city>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vincent PIRIOU, MD</last_name>
      <email>vincent.piriou@chu-lyon.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Poitiers</name>
      <address>
        <city>Poitiers</city>
        <zip>86000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marion VERDAGUER, MD</last_name>
      <email>marion.verdaguer@chu-poitiers.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Reims</name>
      <address>
        <city>Reims</city>
        <zip>51100</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jean-Marc MALINVOSKY, MD-PHD</last_name>
      <email>jmmalinovsky@chu-reims.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Rouen</name>
      <address>
        <city>Rouen</city>
        <zip>76000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yannick MEUNIER, MD</last_name>
      <email>yannick.meunier@chu-rouen.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Saint Etienne</name>
      <address>
        <city>Saint- Etienne</city>
        <zip>42055</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Charles DZVIGA, MD</last_name>
      <email>c.dzviga@magic.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Strasbourg</name>
      <address>
        <city>Strasbourg</city>
        <zip>670000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fréderic DE BLAY, MD- PHD</last_name>
      <email>frederic.deblay@chru-strasbourg.fr</email>
    </contact>
    <contact_backup>
      <last_name>Paul-Michel Mertes, MD- PHD</last_name>
      <email>paul-michel.mertes@chru-strasbourg.fr</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>CHU de Toulouse</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alain DIDIER, MD-PHD</last_name>
      <email>didier.a@chu-toulouse.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de TOURS</name>
      <address>
        <city>Tours</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cyrille HOARAU, Dr</last_name>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>May 12, 2014</study_first_submitted>
  <study_first_submitted_qc>September 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>December 26, 2018</last_update_submitted>
  <last_update_submitted_qc>December 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>anaphylaxis</keyword>
  <keyword>pholcodine</keyword>
  <keyword>neuromuscular blocking agents</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anaphylaxis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pholcodine</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/NCT02250729
org study id: 2012-A01735-38
nct id: NCT02250729
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has dmc: Yes
The main objective of this study is to compare pholcodine exposure in patients having
      presented with a perianaesthetic anaphylactic reaction to a NMBA (cases) to pholcodine
      exposure in matched anaesthetised patients with injection of NMBA, who did not present with
      an anaphylactic reaction (controls).

      The secondary objectives of the study are:

        -  To compare anti-pholcodine IgE, anti-ammonium IV IgE and total IgE levels between the
           case and control groups.

        -  To study the concordance between exposure to pholcodine in cases and controls, by means
           of a patient self-questionnaire on the one hand and, on the other hand, by a
           computerized drug history, supplemented where relevant by the drug master file.

        -  To study the impact of taking 1, 2 or 3 sources in account for pholcodine exposition.

        -  To study the association between exposure to pholcodine and the presence/levels of
           pholcodine-specific IgE, reflecting sensitisation to pholcodine.

        -  To study NMBA and pholcodine cross-sensitisation by testing skin reactions to pholcodine
           in case patients allergic to (at least) one NMBA.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Exposure to pholcodine
time frame: within the 12 months before the anesthetic procedure
description: Exposure is measured by autoquestionnaire, patient's pharmaceutical file and drug history by the pharmacist's
measure: Anti-pholcodine IgE, anti-ammonium IV IgE and total IgE levels between the case and control groups.
time frame: Between 1 day to 12 weeks after the general anesthetic procedure
description: Cases: 6 to 12 weeks after the general anesthetic procedure (corresponding to the day of inclusion) Controls: during their hospitalisation after the general anesthetic procedure (Maximum 90 days after the general anesthetic procedure, corresponding to the day of inclusion)
measure: Concordance between exposure to pholcodine in cases and controls, by means of a patient self-questionnaire on the one hand and, on the other hand, by a computerized drug history, supplemented where relevant by the drug master file.
time frame: within the 12 months preceeding the general anesthesia
measure: Impact of non subjective sources in pholcodine exposure assessment
time frame: within the 12 months preceeding general anesthetic procedure
description: We will study if pholcodine exposure criteria measured by autoquestionnaire is modified by taking into account non subjectives sources which are the patient's pharmaceutical file and his drug history by his pharmacist's
measure: Association between exposure to pholcodine and the presence/levels of pholcodine-specific IgE, reflecting sensitisation to pholcodine.
time frame: within the 12 months preceding the general anesthetic procedure
description: IgE measurements: total IgE, IgE specific for pholcodine, quaternary ammoniums (KU/L)
measure: NMBA and pholcodine cross-sensitisation by testing skin reactions to pholcodine in case patients allergic to one NMBA.
time frame: 6 to 12 weeks after the general anesthetic procedure
description: Only for Cases :
Intradermal tests with diluted pholcodine. Intradermal tests with diluted NMBAs (as usual)
arm group label: cases with NMBA anaphylaxis
arm group type: Experimental
description: Patients who experienced NMBA anaphylaxis during anesthesia
arm group label: controls
arm group type: Other
description: Patients who underwent anesthesia with NMBA injection but did not experience anaphylaxis
intervention type: Other
intervention name: intradermal pholcodine allergy test in cases
arm group label: cases with NMBA anaphylaxis
intervention type: Other
intervention name: Blood sampling
arm group label: cases with NMBA anaphylaxis
arm group label: controls
criteria: 
gender: All
minimum age: 2 Years
maximum age: N/A
healthy volunteers: No
last name: Pierre GILLET, PU-PH MD
role: Principal Investigator
affiliation: CHU de Nancy
last name: Paul-Michel MERTES, PU-PH MD
role: Study Director
affiliation: CHU de Strasbourg
last name: Pierre Gillet, MD PhD
email: pierre.gillet@univ.lorraine.fr
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country: France
responsible party type: Sponsor
mesh term: Anaphylaxis
mesh term: Pholcodine