<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/NCT03798899</url>
  </required_header>
  <id_info>
    <org_study_id>MR311-4501</org_study_id>
    <secondary_id>2017-004469-28</secondary_id>
    <nct_id>NCT03798899</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Penthrox® Combined With a Standard Analgesia (SoC) in Adult Patients Admitted to the Emergency Department With Moderate to Severe Pain Associated With Trauma</brief_title>
  <acronym>Pen ASAP</acronym>
  <official_title>Multicentre, Randomised, Double-blind Study Assessing the Efficacy and Safety of Penthrox® Combined With a Standard Analgesia (SoC) in Comparison to a Placebo Combined With a Standard Analgesia (SoC) in Adult Patients Admitted to the Emergency Department With Moderate to Severe Pain Associated With Trauma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mundipharma SAS</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AXONAL</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Exystat</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Mundipharma SAS</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>
      A phase 4 randomised, double-blind study to assess the efficacy and safety of Penthrox® used&#xD;
      from the outset in multimodal analgesia, in combination with the standard analgesic protocol&#xD;
      used in the department, for conscious adult patients presenting in an emergency department&#xD;
      with moderate to severe pain associated with a trauma&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      On admission, the patient pain score will be measured using a numerical scale (NRS-11) to&#xD;
      verify the eligibility of the patient in the study (NRS ≥ 4).&#xD;
&#xD;
      At the time of randomisation, the patient's pain score will be measured using a VAS in order&#xD;
      to verify the patient's eligibility for randomisation (VAS ≥ 40).&#xD;
&#xD;
      Admissible patients will be randomised by IWRS (Interactive Web Response System) to receive:&#xD;
&#xD;
        -  Either Penthrox® + SoC&#xD;
&#xD;
        -  Or placebo + SoC (Figure 1). Randomisation will be stratified by sex, site and according&#xD;
           to the baseline pain score (NRS 4-5 for a moderate-intensity pain versus NS 6-10 for a&#xD;
           severe-intensity pain).&#xD;
&#xD;
      The IWRS system will be based on the fact of including 50% patients with moderate pain and&#xD;
      50% patients with severe pain.&#xD;
&#xD;
      Close weekly monitoring of this ratio will be set up. The decision to no longer include&#xD;
      patients in one of the study subgroups according to pain, if necessary, or to change this&#xD;
      ratio, will be made by the Study Sponsor and in agreement with the study&#xD;
      investigator-coordinator and the study scientific committee. A minimum of 150 patients will&#xD;
      be included in the severe pain subgroup (EN 6-10).&#xD;
&#xD;
      The treatment (preparation of two inhalers, the second only being given to the patient on&#xD;
      request) will only be administered once intermittently or continuously to patients on&#xD;
      admission to the study (D0, T0).&#xD;
&#xD;
      The pain score will be assessed using the VAS every 5 minutes up to 20 minutes, then at 30,&#xD;
      60, 90, and 120 minutes after the start of study treatment (T0). Patients will be assessed&#xD;
      until their discharge from the emergency departments (hospitalization, transfer home,&#xD;
      transfer to the operating room) or up to 120 minutes after the initial administration.&#xD;
&#xD;
      A telephone interview will take place 14 (± 2) days after the first treatment administration&#xD;
      to assess the medium-term safety of the product.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 14, 2018</start_date>
  <completion_date type="Actual">December 20, 2018</completion_date>
  <primary_completion_date type="Actual">December 20, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>time until pain relief defined by the duration between the start of the study treatment (T0) and pain relief</measure>
    <time_frame>through study completion, maximum of 2 hours</time_frame>
    <description>Measured on Pain intensity visual analogue scale (PI-VAS) 0-100 where 100 is the highest pain</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration between the start of study treatment (T0) and pain relief reported by the patient</measure>
    <time_frame>through study completion, maximum of 2 hours</time_frame>
    <description>Pain measured on PI-VAS, 0-100 where 100 is the highest pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Pain Intensity Difference (PID) measured using the PI-VAS at 5, 10, 15, 20 and 30 minutes after T0</measure>
    <time_frame>baseline to 5, 10, 15, 20 and 30 minutes</time_frame>
    <description>PID for a given assessment time is equal to the VAS score at T0 minus the VAS score at each assessment time provided in the study. Pain measured on PI-VAS, 0-100 where 100 is the highest pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative Pain Intensity Difference measured using the PI-VAS at 5, 10, 15, 20 and 30 minutes after T0</measure>
    <time_frame>baseline to 5, 10, 15, 20 and 30 minutes</time_frame>
    <description>Relative pain intensity difference for a given assessment time is equal to the VAS score at T0 minus the VAS score at each assessment time provided in the study divided by the VAS score at T0. Pain measured on PI-VAS, 0-100 where 100 is the highest pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain relief defined by pain intensity &lt; 40 mm on the PI-VAS scale at 5, 10, 15, 20 and 30 minutes after T0</measure>
    <time_frame>baseline to 5, 10, 15, 20 and 30 minutes</time_frame>
    <description>Pain measured on PI-VAS, 0-100 where 100 is the highest pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response defined by pain reduction of 20 mm on the PI-VAS at 5, 10, 15, 20 and 30 minutes after T0</measure>
    <time_frame>baseline to 5, 10, 15, 20 and 30 minutes</time_frame>
    <description>Pain measured on PI-VAS, 0-100 where 100 is the highest pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response defined by pain reduction of 30% mm on the PI-VAS at 5, 10, 15, 20 and 30 minutes after T0</measure>
    <time_frame>baseline to 5, 10, 15, 20 and 30 minutes</time_frame>
    <description>Pain measured on PI-VAS, 0-100 where 100 is the highest pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Summed Pain Intensity Difference (SPID) measured on the PI-VAS at 5, 10, 15, 20 and 30 minutes</measure>
    <time_frame>baseline to 30 minutes</time_frame>
    <description>SPID will be calculated by using the pain intensity difference (PID) at each of these assessment times provided in the study. SPID is the sum of the PID at each study assessment time, weighted by using the time elapsed since the previous assessment, and approaches the area under the curve for the PID over time. Relative to the VAS score, the SPID measurement has the advantage of considering individual differences at the level of initial pain intensity (baseline) as well as time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients attaining an SPID of at least 33%</measure>
    <time_frame>through study completion, maximum of 2 hours</time_frame>
    <description>The proportion of patients attaining an SPID of at least 33% of the maximum possible SPID will be calculated (maximum possible SPID is the the value that would be obtained if the patient was pain free (VAS=0) for the entire study period); this will be considered as corresponding to the responder rate. A % SPID of 33% was previously established as being a clinically significant measurement in pain results.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantity of opioids received (in milligrams of morphine)</measure>
    <time_frame>through study completion, maximum of 2 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description of the Standard of Care and concomitant analgesic treatments</measure>
    <time_frame>through study completion, maximum of 2 hours</time_frame>
    <description>Descriptions from the World Health Organization (http://www.who.int/cancer/palliative/painladder/en/): Type of drug, doses, administration periods, and treatment duration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sedation score (Ramsay scale)</measure>
    <time_frame>through study completion, maximum of 2 hours</time_frame>
    <description>Measured using the Ramsay sedation scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction score (Likert 0-5 scale)</measure>
    <time_frame>through study completion, maximum of 2 hours</time_frame>
    <description>Satisfaction is rated by patient as Poor, Fair, Good, Very Good or Excellent</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physician satisfaction scale (Likert 0-5 scale)</measure>
    <time_frame>through study completion, maximum of 2 hours</time_frame>
    <description>Satisfaction is rated by Physician as Poor, Fair, Good, Very Good or Excellent</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nurse satisfaction scale (Likert 0-5 scale)</measure>
    <time_frame>through study completion, maximum of 2 hours</time_frame>
    <description>Satisfaction is rated by Nurse as Poor, Fair, Good, Very Good or Excellent</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay (LOS) in emergency</measure>
    <time_frame>through study completion, maximum of 2 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess the time until medical decision to discharge</measure>
    <time_frame>through study completion, maximum of 2 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events (AE) not associated with the underlying trauma and occurring during treatment</measure>
    <time_frame>through study completion, maximum of 2 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in blood pressure</measure>
    <time_frame>baseline to 30 minutes</time_frame>
    <description>The Blood Systolic and Diastolic pressure (mmHg) will be measured at baseline and 30 minutes. The difference between the values will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in oxygen saturation</measure>
    <time_frame>baseline to 30 minutes</time_frame>
    <description>Oxygen saturation (%) will be measured at baseline and 30 minutes. The difference between the values will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in respiration rate</measure>
    <time_frame>baseline to 30 minutes</time_frame>
    <description>Respiration rate (breaths/min) will be measured at baseline and 30 minutes. The difference between the values will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in heart rate</measure>
    <time_frame>baseline to 30 minutes</time_frame>
    <description>Heart rate (beats/min) will be measured at baseline and 30 minutes. The difference between the values will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of tachycardia, hypotension, hypertension and respiratory depression</measure>
    <time_frame>through study completion, maximum of 2 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of premature withdrawal of patients for safety or tolerability reasons</measure>
    <time_frame>through study completion, maximum of 2 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">360</enrollment>
  <condition>Pain, Acute</condition>
  <arm_group>
    <arm_group_label>Penthrox® (Methoxyflurane)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be asked to inhale Penthrox® intermittently or continuously to obtain adequate analgesia.&#xD;
Penthrox® or placebo will be administered in combination with standard analgesic treatments usually used according to the emergency department protocol (SoC).&#xD;
Duration of treatment: 1 administration (with a maximum of 2 inhalers) during passage to emergency.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal Saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients will be asked to inhale Penthrox® intermittently or continuously to obtain adequate analgesia.&#xD;
Penthrox® or placebo will be administered in combination with standard analgesic treatments usually used according to the emergency department protocol (SoC).&#xD;
Duration of treatment: 1 administration (with a maximum of 2 inhalers) during passage to emergency.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Methoxyflurane</intervention_name>
    <description>PENTHROX 3mL inhalation vapour, liquid</description>
    <arm_group_label>Penthrox® (Methoxyflurane)</arm_group_label>
    <other_name>Penthrox®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal Saline</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Normal Saline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women aged 18 or older&#xD;
&#xD;
          -  Patients (in an emergency, parent or relative) who dated and signed their informed&#xD;
             consent to participate in the study&#xD;
&#xD;
          -  Patients admitted to the emergency department due to a trauma&#xD;
&#xD;
          -  Patients having a pain score ≥ 4 measured using a numerical scale (NRS) at the time of&#xD;
             admission to emergency departments.&#xD;
&#xD;
          -  Patients having a pain score ≥ 40 measured using the VAS at the time of randomisation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Life-threatening conditions requiring immediate admission to the operating theatre or&#xD;
             the intensive care unit;&#xD;
&#xD;
          -  Impaired consciousness according to the investigator regardless of the cause,&#xD;
             including head trauma or drug or alcohol consumption;&#xD;
&#xD;
          -  Acute medicinal or alcohol intoxication, according to the investigator;&#xD;
&#xD;
          -  Pregnant woman or woman at risk of pregnancy and not using highly effective&#xD;
             contraception methods or known lactation;&#xD;
&#xD;
          -  Analgesic treatment within 5 hours (8 h for sodium diclofenac) prior to admission,&#xD;
             except for paracetamol, which is allowed;&#xD;
&#xD;
          -  Treatment with nitrous oxide within 5 hours before presentation at the emergency&#xD;
             department;&#xD;
&#xD;
          -  Use of analgesics for chronic pain;&#xD;
&#xD;
          -  Prior use of Penthrox®;&#xD;
&#xD;
          -  Use of an investigational product one month before presentation at the emergency&#xD;
             department;&#xD;
&#xD;
          -  Hypersensitivity to Penthrox® or any other fluoridated anesthetic;&#xD;
&#xD;
          -  History of signs of hepatic lesions after use of methoxyflurane or after anaesthesia&#xD;
             by a halogenated hydrocarbon;&#xD;
&#xD;
          -  Malignant hyperthermia: Known malignant hyperthermia or patient genetic predisposition&#xD;
             or patient or family history of serious adverse reactions;&#xD;
&#xD;
          -  Clinical evidence of respiratory depression according to the investigator;&#xD;
&#xD;
          -  Clinical evidence of cardiovascular instability according to the investigator;&#xD;
&#xD;
          -  Clinical renal or hepatic damage, according to the investigator, pre-existing or&#xD;
             known;&#xD;
&#xD;
          -  Presence of any other clinical condition that can, according to the investigator's&#xD;
             opinion, have an impact on the patient's ability to participate in the study or the&#xD;
             results of the study.&#xD;
&#xD;
          -  Individuals protected by law&#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>A Ricard-Hibon, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHG Pontoise / SAMU 95</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CH Annecy Genevois</name>
      <address>
        <city>Annecy</city>
        <zip>74374</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GH Carnelle Porte de l'Oise</name>
      <address>
        <city>Beaumont-sur-Oise</city>
        <zip>95260</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Avicenne - APHP</name>
      <address>
        <city>Bobigny</city>
        <zip>93000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU Lille</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Edouard Herriot</name>
      <address>
        <city>Lyon</city>
        <zip>69437</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospice civil de Lyon</name>
      <address>
        <city>Pierre Bénite</city>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH René Dubos</name>
      <address>
        <city>Pontoise</city>
        <zip>95300</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Purpan</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>November 9, 2018</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>January 7, 2019</last_update_submitted>
  <last_update_submitted_qc>January 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2019</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>Methoxyflurane</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/NCT03798899
org study id: MR311-4501
secondary id: 2017-004469-28
nct id: NCT03798899
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A phase 4 randomised, double-blind study to assess the efficacy and safety of Penthrox® used
      from the outset in multimodal analgesia, in combination with the standard analgesic protocol
      used in the department, for conscious adult patients presenting in an emergency department
      with moderate to severe pain associated with a trauma
On admission, the patient pain score will be measured using a numerical scale (NRS-11) to
      verify the eligibility of the patient in the study (NRS ≥ 4).

      At the time of randomisation, the patient's pain score will be measured using a VAS in order
      to verify the patient's eligibility for randomisation (VAS ≥ 40).

      Admissible patients will be randomised by IWRS (Interactive Web Response System) to receive:

        -  Either Penthrox® + SoC

        -  Or placebo + SoC (Figure 1). Randomisation will be stratified by sex, site and according
           to the baseline pain score (NRS 4-5 for a moderate-intensity pain versus NS 6-10 for a
           severe-intensity pain).

      The IWRS system will be based on the fact of including 50% patients with moderate pain and
      50% patients with severe pain.

      Close weekly monitoring of this ratio will be set up. The decision to no longer include
      patients in one of the study subgroups according to pain, if necessary, or to change this
      ratio, will be made by the Study Sponsor and in agreement with the study
      investigator-coordinator and the study scientific committee. A minimum of 150 patients will
      be included in the severe pain subgroup (EN 6-10).

      The treatment (preparation of two inhalers, the second only being given to the patient on
      request) will only be administered once intermittently or continuously to patients on
      admission to the study (D0, T0).

      The pain score will be assessed using the VAS every 5 minutes up to 20 minutes, then at 30,
      60, 90, and 120 minutes after the start of study treatment (T0). Patients will be assessed
      until their discharge from the emergency departments (hospitalization, transfer home,
      transfer to the operating room) or up to 120 minutes after the initial administration.

      A telephone interview will take place 14 (± 2) days after the first treatment administration
      to assess the medium-term safety of the product.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: time until pain relief defined by the duration between the start of the study treatment (T0) and pain relief
time frame: through study completion, maximum of 2 hours
description: Measured on Pain intensity visual analogue scale (PI-VAS) 0-100 where 100 is the highest pain
measure: Duration between the start of study treatment (T0) and pain relief reported by the patient
time frame: through study completion, maximum of 2 hours
description: Pain measured on PI-VAS, 0-100 where 100 is the highest pain
measure: Absolute Pain Intensity Difference (PID) measured using the PI-VAS at 5, 10, 15, 20 and 30 minutes after T0
time frame: baseline to 5, 10, 15, 20 and 30 minutes
description: PID for a given assessment time is equal to the VAS score at T0 minus the VAS score at each assessment time provided in the study. Pain measured on PI-VAS, 0-100 where 100 is the highest pain
measure: Relative Pain Intensity Difference measured using the PI-VAS at 5, 10, 15, 20 and 30 minutes after T0
time frame: baseline to 5, 10, 15, 20 and 30 minutes
description: Relative pain intensity difference for a given assessment time is equal to the VAS score at T0 minus the VAS score at each assessment time provided in the study divided by the VAS score at T0. Pain measured on PI-VAS, 0-100 where 100 is the highest pain
measure: Pain relief defined by pain intensity < 40 mm on the PI-VAS scale at 5, 10, 15, 20 and 30 minutes after T0
time frame: baseline to 5, 10, 15, 20 and 30 minutes
description: Pain measured on PI-VAS, 0-100 where 100 is the highest pain
measure: Response defined by pain reduction of 20 mm on the PI-VAS at 5, 10, 15, 20 and 30 minutes after T0
time frame: baseline to 5, 10, 15, 20 and 30 minutes
description: Pain measured on PI-VAS, 0-100 where 100 is the highest pain
measure: Response defined by pain reduction of 30% mm on the PI-VAS at 5, 10, 15, 20 and 30 minutes after T0
time frame: baseline to 5, 10, 15, 20 and 30 minutes
description: Pain measured on PI-VAS, 0-100 where 100 is the highest pain
measure: Summed Pain Intensity Difference (SPID) measured on the PI-VAS at 5, 10, 15, 20 and 30 minutes
time frame: baseline to 30 minutes
description: SPID will be calculated by using the pain intensity difference (PID) at each of these assessment times provided in the study. SPID is the sum of the PID at each study assessment time, weighted by using the time elapsed since the previous assessment, and approaches the area under the curve for the PID over time. Relative to the VAS score, the SPID measurement has the advantage of considering individual differences at the level of initial pain intensity (baseline) as well as time.
measure: Proportion of patients attaining an SPID of at least 33%
time frame: through study completion, maximum of 2 hours
description: The proportion of patients attaining an SPID of at least 33% of the maximum possible SPID will be calculated (maximum possible SPID is the the value that would be obtained if the patient was pain free (VAS=0) for the entire study period); this will be considered as corresponding to the responder rate. A % SPID of 33% was previously established as being a clinically significant measurement in pain results.
measure: Quantity of opioids received (in milligrams of morphine)
time frame: through study completion, maximum of 2 hours
measure: Description of the Standard of Care and concomitant analgesic treatments
time frame: through study completion, maximum of 2 hours
description: Descriptions from the World Health Organization (http://www.who.int/cancer/palliative/painladder/en/): Type of drug, doses, administration periods, and treatment duration
measure: Sedation score (Ramsay scale)
time frame: through study completion, maximum of 2 hours
description: Measured using the Ramsay sedation scale
measure: Patient satisfaction score (Likert 0-5 scale)
time frame: through study completion, maximum of 2 hours
description: Satisfaction is rated by patient as Poor, Fair, Good, Very Good or Excellent
measure: Physician satisfaction scale (Likert 0-5 scale)
time frame: through study completion, maximum of 2 hours
description: Satisfaction is rated by Physician as Poor, Fair, Good, Very Good or Excellent
measure: Nurse satisfaction scale (Likert 0-5 scale)
time frame: through study completion, maximum of 2 hours
description: Satisfaction is rated by Nurse as Poor, Fair, Good, Very Good or Excellent
measure: Length of stay (LOS) in emergency
time frame: through study completion, maximum of 2 hours
measure: Assess the time until medical decision to discharge
time frame: through study completion, maximum of 2 hours
measure: Incidence of adverse events (AE) not associated with the underlying trauma and occurring during treatment
time frame: through study completion, maximum of 2 hours
measure: Change in blood pressure
time frame: baseline to 30 minutes
description: The Blood Systolic and Diastolic pressure (mmHg) will be measured at baseline and 30 minutes. The difference between the values will be calculated.
measure: Change in oxygen saturation
time frame: baseline to 30 minutes
description: Oxygen saturation (%) will be measured at baseline and 30 minutes. The difference between the values will be calculated.
measure: Change in respiration rate
time frame: baseline to 30 minutes
description: Respiration rate (breaths/min) will be measured at baseline and 30 minutes. The difference between the values will be calculated.
measure: Change in heart rate
time frame: baseline to 30 minutes
description: Heart rate (beats/min) will be measured at baseline and 30 minutes. The difference between the values will be calculated.
measure: Incidence of tachycardia, hypotension, hypertension and respiratory depression
time frame: through study completion, maximum of 2 hours
measure: Incidence of premature withdrawal of patients for safety or tolerability reasons
time frame: through study completion, maximum of 2 hours
arm group label: Penthrox® (Methoxyflurane)
arm group type: Experimental
description: Patients will be asked to inhale Penthrox® intermittently or continuously to obtain adequate analgesia.
Penthrox® or placebo will be administered in combination with standard analgesic treatments usually used according to the emergency department protocol (SoC).
Duration of treatment: 1 administration (with a maximum of 2 inhalers) during passage to emergency.
arm group label: Normal Saline
arm group type: Placebo Comparator
description: Patients will be asked to inhale Penthrox® intermittently or continuously to obtain adequate analgesia.
Penthrox® or placebo will be administered in combination with standard analgesic treatments usually used according to the emergency department protocol (SoC).
Duration of treatment: 1 administration (with a maximum of 2 inhalers) during passage to emergency.
intervention type: Drug
intervention name: Methoxyflurane
description: PENTHROX 3mL inhalation vapour, liquid
arm group label: Penthrox® (Methoxyflurane)
other name: Penthrox®
intervention type: Drug
intervention name: Normal Saline
description: Placebo
arm group label: Normal Saline
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: A Ricard-Hibon, Dr
role: Principal Investigator
affiliation: CHG Pontoise / SAMU 95
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country: France
responsible party type: Sponsor
mesh term: Emergencies
mesh term: Acute Pain
mesh term: Methoxyflurane