<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/NCT02243826</url>
  </required_header>
  <id_info>
    <org_study_id>CHU-206</org_study_id>
    <secondary_id>2014-001452-28</secondary_id>
    <nct_id>NCT02243826</nct_id>
  </id_info>
  <brief_title>Impact of 50% Nitrous Oxide Inhalation on Pain and Anxiety Induced by Lumbar Puncture: a Double-blind Randomized Controlled Trial</brief_title>
  <official_title>Impact of 50% Nitrous Oxide Inhalation on Pain and Anxiety Induced by Lumbar Puncture: a Double-blind Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Clermont-Ferrand</source>
  <brief_summary>
    <textblock>
      This study is designed to evaluate the analgesic effect of nitrous oxide (N2O) on the pain&#xD;
      induced during lumbar puncture.&#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 never been investigated&#xD;
      properly.&#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>Recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">October 2015</completion_date>
  <primary_completion_date type="Anticipated">October 2015</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximal pain level during the procedure</measure>
    <time_frame>at day 1</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximal anxiety level during the procedure</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety evaluated by 2 questionnaires: the Hospital Anxiety and Depression (HAD) State Trait Anxiety Inventory (STAI)</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients presenting side effects</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total duration of the lumbar puncture</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients that would accept another lumbar puncture in the same conditions</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">66</enrollment>
  <condition>Lumbar Puncture</condition>
  <arm_group>
    <arm_group_label>N20</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One group will inhale N2O for the 5 minutes before the puncture and during the rest of the procedure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>compressed air</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The second group will inhale compressed air during the same period of time</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>50:50 mixture of nitrous oxide/oxygen</intervention_name>
    <arm_group_label>N20</arm_group_label>
    <arm_group_label>compressed air</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients coming in the neurology department for a scheduled lumbar puncture&#xD;
&#xD;
          -  18 to 60 years.&#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;26/30&#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>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pierre CLAVELOU</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Clermont-Ferrand</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>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patrick LACARIN</last_name>
      <phone>04 73 75 11 95</phone>
      <email>placarin@chu-clermontferrand.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2014</study_first_posted>
  <last_update_submitted>September 18, 2015</last_update_submitted>
  <last_update_submitted_qc>September 18, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 21, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lumbar puncture</keyword>
  <keyword>Adults</keyword>
  <keyword>Nitrous oxide</keyword>
  <keyword>Procedural pain</keyword>
  <keyword>Procedural anxiety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</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/NCT02243826
org study id: CHU-206
secondary id: 2014-001452-28
nct id: NCT02243826
lead sponsor: 
This study is designed to evaluate the analgesic effect of nitrous oxide (N2O) on the pain
      induced during lumbar puncture.
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 never been investigated
      properly.

      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
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Maximal pain level during the procedure
time frame: at day 1
measure: Maximal anxiety level during the procedure
time frame: at day 1
measure: Anxiety evaluated by 2 questionnaires: the Hospital Anxiety and Depression (HAD) State Trait Anxiety Inventory (STAI)
time frame: at day 1
measure: Proportion of patients presenting side effects
time frame: at day 1
measure: Total duration of the lumbar puncture
time frame: at day 1
measure: Proportion of patients that would accept another lumbar puncture in the same conditions
time frame: at day 1
arm group label: N20
arm group type: Experimental
description: One group will inhale N2O for the 5 minutes before the puncture and during the rest of the procedure.
arm group label: compressed air
arm group type: Other
description: The second group will inhale compressed air during the same period of time
intervention type: Drug
intervention name: 50:50 mixture of nitrous oxide/oxygen
arm group label: N20
arm group label: compressed air
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Pierre CLAVELOU
role: Principal Investigator
affiliation: University Hospital, Clermont-Ferrand
last name: Patrick LACARIN
phone: 04 73 75 11 95
email: placarin@chu-clermontferrand.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Wounds and Injuries
mesh term: Nitrous Oxide