<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/NCT03228628</url>
  </required_header>
  <id_info>
    <org_study_id>CHU-342</org_study_id>
    <secondary_id>2017-002750-37</secondary_id>
    <nct_id>NCT03228628</nct_id>
  </id_info>
  <brief_title>Nitrous Oxide for Lumbar Puncture</brief_title>
  <acronym>NO for LP</acronym>
  <official_title>Impact of 50% Nitrous Oxide Inhalation on Pain and Anxiety Induced by Lumbar Puncture: a Multicenter Double-blind Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospital, Bordeaux</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Inserm U1107, NeuroDol</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Université d'Auvergne</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Clermont-Ferrand</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Lumbar puncture (LP) is a frequent exam that can cause pain and anxiety. In a pilot&#xD;
      single-center study, it has been shown that nitrous oxide use during the procedure was able&#xD;
      to reduce both pain and anxiety (Moisset et al., Eur J Neurol 2017). The goal of this&#xD;
      multi-center trial is to confirm these results in a larger and more heterogeneous group of&#xD;
      patients having a LP.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Nitrous oxide (N2O) has analgesic and anxiolytic properties that are known for more than a&#xD;
      century. Nonetheless, it's use during lumbar puncture in adults has only been investigated in&#xD;
      a single-centre study.&#xD;
&#xD;
      Thus, this study is designed to evaluate the analgesic effect of N2O on the pain induced&#xD;
      during lumbar puncture.&#xD;
&#xD;
      Patients with scheduled lumbar puncture realized for diagnosis purposes will be randomized in&#xD;
      2 groups. One group will inhale N2O for the 5 minutes before the puncture and during the rest&#xD;
      of the procedure. The second group will inhale compressed air during the same period of time.&#xD;
      Neither the investigator realizing the lumbar puncture, nor the patient will know which type&#xD;
      of gaz they are inhaling (double-blinding).&#xD;
&#xD;
      The maximal pain level that occurred during the procedure will be evaluated on a Numerical&#xD;
      Rating Scale (NRS). NRS will also be used to evaluate the maximal anxiety induced by the&#xD;
      procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 1, 2017</start_date>
  <completion_date type="Anticipated">September 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">June 6, 2018</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>
    <intervention_model_description>1:1 randomization to receive experimental treatment (50% N2O - 50% O2) or placebo (Medical Air: 22% O2 - 78% N2)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>double blinding. Gaz bottles are in undistinguishable boxes. Neither the patients nor the person doing the LP and the evaluation of pain and anxiety will know the treatment used</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of patients with significant pain</measure>
    <time_frame>2-3 minutes after the end of gaz inhalation</time_frame>
    <description>maximal pain perceived during the lumbar puncture evaluated using a simple numeric 0-10 pain scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with significant anxiety</measure>
    <time_frame>2-3 minutes after the end of gaz inhalation</time_frame>
    <description>maximal anxiety perceived during the lumbar puncture evaluated using a simple numeric 0-10 scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analgesic efficacy measured with pain as a continuous variable</measure>
    <time_frame>2-3 minutes after the end of gaz inhalation.</time_frame>
    <description>maximal pain perceived during the lumbar puncture evaluated using a simple numeric 0-10 pain scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiolytic efficacy measured with anxiety as a continuous variable</measure>
    <time_frame>2-3 minutes after the end of gaz inhalation</time_frame>
    <description>maximal anxiety perceived during the lumbar puncture evaluated using a simple numeric 0-10 scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain during the procedure evaluated one hour after the end of the lumbar puncture</measure>
    <time_frame>1 hour after the end of gaz inhalation</time_frame>
    <description>maximal pain and anxiety perceived during the lumbar puncture evaluated using a simple numeric 0-10 scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety during the procedure evaluated one hour after the end of the lumbar puncture</measure>
    <time_frame>1 hour after the end of gaz inhalation</time_frame>
    <description>maximal pain and anxiety perceived during the lumbar puncture evaluated using a simple numeric 0-10 scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side effects</measure>
    <time_frame>from the beginning of gaz inhalation to 24 hours later</time_frame>
    <description>every side effects reported by the patients during the procedure up to 24 hours after the lumbar puncture, including post-puncture puncture headache</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of age on side effects</measure>
    <time_frame>during the procedure and the 24 hours after</time_frame>
    <description>incidence and type of side effects according to patient age</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Induced cost</measure>
    <time_frame>at day 1</time_frame>
    <description>supplementary cost induced by the use of nitrous oxide inhalation for a total of 81 patients throughout the study</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">162</enrollment>
  <condition>Pain</condition>
  <condition>Anxiety</condition>
  <arm_group>
    <arm_group_label>Nitrous oxide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>will inhale experimental treatment (50% N2O - 50% O2)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>will inhale medical air (22% O2 - 78% N2)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fixed 50:50 mixture of nitrous oxide and oxygen</intervention_name>
    <description>Gaz inhalation will start 5 minutes before the puncture and will be continued until the end of the procedure.</description>
    <arm_group_label>Nitrous oxide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>inhale medical air (22% O2 - 78% N2)</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients coming in the neurology department for a lumbar puncture&#xD;
&#xD;
          -  at least 18&#xD;
&#xD;
          -  no previous use of nitrous oxide&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  contra-indication to nitrous oxide use&#xD;
&#xD;
          -  Body Mass Index&gt;35&#xD;
&#xD;
          -  Mini Mental State Examination &lt;24/30&#xD;
&#xD;
          -  Temperature &gt;38°C&#xD;
&#xD;
          -  Confusion&#xD;
&#xD;
          -  Patient unable to communicate verbaly&#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>Xavier MOISSET, MD-PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Clermont-Ferrand, Inserm, Neuro-Dol</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Patrick LACARIN</last_name>
    <phone>04 73 75 11 95</phone>
    <email>placarin@chu-clermontferrand.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU de Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <state>Auvergne</state>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>Patrick LACARIN</last_name>
      <phone>04 73 75 11 95</phone>
      <email>placarin@chu-clermontferrand.fr</email>
    </contact>
    <investigator>
      <last_name>Xavier MOISSET, MD-PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sandra VUKUSIC, MD-PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Bruno BROCHET, MD-PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Pierre CLAVELOU, MD-PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 19, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>July 21, 2017</last_update_submitted>
  <last_update_submitted_qc>July 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Spinal puncture</keyword>
  <keyword>Pain</keyword>
  <keyword>Anxiety</keyword>
  <keyword>Nitrous oxyde</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nitrous Oxide</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/NCT03228628
org study id: CHU-342
secondary id: 2017-002750-37
nct id: NCT03228628
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Lumbar puncture (LP) is a frequent exam that can cause pain and anxiety. In a pilot
      single-center study, it has been shown that nitrous oxide use during the procedure was able
      to reduce both pain and anxiety (Moisset et al., Eur J Neurol 2017). The goal of this
      multi-center trial is to confirm these results in a larger and more heterogeneous group of
      patients having a LP.
Nitrous oxide (N2O) has analgesic and anxiolytic properties that are known for more than a
      century. Nonetheless, it's use during lumbar puncture in adults has only been investigated in
      a single-centre study.

      Thus, this study is designed to evaluate the analgesic effect of N2O on the pain induced
      during lumbar puncture.

      Patients with scheduled lumbar puncture realized for diagnosis purposes will be randomized in
      2 groups. One group will inhale N2O for the 5 minutes before the puncture and during the rest
      of the procedure. The second group will inhale compressed air during the same period of time.
      Neither the investigator realizing the lumbar puncture, nor the patient will know which type
      of gaz they are inhaling (double-blinding).

      The maximal pain level that occurred during the procedure will be evaluated on a Numerical
      Rating Scale (NRS). NRS will also be used to evaluate the maximal anxiety induced by the
      procedure.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 1:1 randomization to receive experimental treatment (50% N2O - 50% O2) or placebo (Medical Air: 22% O2 - 78% N2)
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: double blinding. Gaz bottles are in undistinguishable boxes. Neither the patients nor the person doing the LP and the evaluation of pain and anxiety will know the treatment used
measure: Proportion of patients with significant pain
time frame: 2-3 minutes after the end of gaz inhalation
description: maximal pain perceived during the lumbar puncture evaluated using a simple numeric 0-10 pain scale
measure: Proportion of patients with significant anxiety
time frame: 2-3 minutes after the end of gaz inhalation
description: maximal anxiety perceived during the lumbar puncture evaluated using a simple numeric 0-10 scale
measure: Analgesic efficacy measured with pain as a continuous variable
time frame: 2-3 minutes after the end of gaz inhalation.
description: maximal pain perceived during the lumbar puncture evaluated using a simple numeric 0-10 pain scale
measure: Anxiolytic efficacy measured with anxiety as a continuous variable
time frame: 2-3 minutes after the end of gaz inhalation
description: maximal anxiety perceived during the lumbar puncture evaluated using a simple numeric 0-10 scale
measure: Pain during the procedure evaluated one hour after the end of the lumbar puncture
time frame: 1 hour after the end of gaz inhalation
description: maximal pain and anxiety perceived during the lumbar puncture evaluated using a simple numeric 0-10 scale
measure: Anxiety during the procedure evaluated one hour after the end of the lumbar puncture
time frame: 1 hour after the end of gaz inhalation
description: maximal pain and anxiety perceived during the lumbar puncture evaluated using a simple numeric 0-10 scale
measure: Side effects
time frame: from the beginning of gaz inhalation to 24 hours later
description: every side effects reported by the patients during the procedure up to 24 hours after the lumbar puncture, including post-puncture puncture headache
measure: Impact of age on side effects
time frame: during the procedure and the 24 hours after
description: incidence and type of side effects according to patient age
measure: Induced cost
time frame: at day 1
description: supplementary cost induced by the use of nitrous oxide inhalation for a total of 81 patients throughout the study
arm group label: Nitrous oxide
arm group type: Experimental
description: will inhale experimental treatment (50% N2O - 50% O2)
arm group label: Placebo
arm group type: Placebo Comparator
description: will inhale medical air (22% O2 - 78% N2)
intervention type: Drug
intervention name: Fixed 50:50 mixture of nitrous oxide and oxygen
description: Gaz inhalation will start 5 minutes before the puncture and will be continued until the end of the procedure.
arm group label: Nitrous oxide
intervention type: Other
intervention name: Placebo
description: inhale medical air (22% O2 - 78% N2)
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Xavier MOISSET, MD-PhD
role: Principal Investigator
affiliation: CHU Clermont-Ferrand, Inserm, Neuro-Dol
last name: Patrick LACARIN
phone: 04 73 75 11 95
email: placarin@chu-clermontferrand.fr
facility: 
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Anxiety Disorders
mesh term: Nitrous Oxide