<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/NCT02200185</url>
  </required_header>
  <id_info>
    <org_study_id>TIMORNEB</org_study_id>
    <nct_id>NCT02200185</nct_id>
  </id_info>
  <brief_title>Titrated Versus High and Low Dose Nebulized Morphine to Reduce Pain in Emergency Settings</brief_title>
  <acronym>TIMORNEB</acronym>
  <official_title>Efficacy and Safety of Nebulized Morphine Given at Two Different Doses Compared to Intravenous Morphine in Post-traumatic Acute Pain: a Randomized Controlled Double Blind Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Monastir</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Monastir</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators test a different technique using morphine to improve pain relief in patient&#xD;
      visiting the emergency department with acute trauma pain, for this we are comparing three&#xD;
      different methods of morphine administration:&#xD;
&#xD;
        -  intravenous titrated morphine&#xD;
&#xD;
        -  low dose nebulized morphine and&#xD;
&#xD;
        -  high dose nebulized morphine&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Trauma patients are frequent in emergency department settings, and often require urgent care.&#xD;
&#xD;
      taking care of this patients consists on taking care of their pain and then the specific&#xD;
      treatment of their traumatic lesions.&#xD;
&#xD;
      actually, the most used medicine and most efficient one in treating pain is morphine, it's&#xD;
      mechanism of action is by acting on receptors located on neuronal cell membranes and inhibit&#xD;
      neurotransmitter release.&#xD;
&#xD;
      The most applied administration root of morphine is by intravenous (IV) titration or IV&#xD;
      continuous perfusion, but until now, there is no clear recommendation concerning the&#xD;
      superiority of this root over other administration techniques such as nebulization.&#xD;
&#xD;
      In this study we aimed to investigate the efficiency, the feasibility and the tolerance of&#xD;
      three morphine administration roots in patients with acute traumatic pain and to clarify the&#xD;
      most adequate one to apply in emergency department settings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</primary_completion_date>
  <phase>N/A</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, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain resolution</measure>
    <time_frame>30 minutes</time_frame>
    <description>primary end point defined by the decrease in intensity pain objectified by a decline in visual analogy pain scale greater than or equal to 50% of its initial value</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>side effects</measure>
    <time_frame>30 minutes</time_frame>
    <description>secondary outcomes combine the occurrence of side effects requiring discontinuation of treatment such as: dizziness, dyspnea, cutaneous rush, vomiting, nausea and pruritus.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">300</enrollment>
  <condition>Post-Traumatic Headache</condition>
  <condition>Acute Pain</condition>
  <arm_group>
    <arm_group_label>IV titrated morphine</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>patient will receive 2 mg morphine each 5 min, associated to continuous nebulisation of saline serum (placebo).&#xD;
Morphine administration is stopped when VAS becomes under 50% and treatment failure is defined as VAS &gt; 50%, 30 minutes after the beginning of the protocol.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low dose nebulised morphine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patient will receive 10 mg of morphine prepared with 4 ml saline serum (SS) and nebulised with 6 l/min flow during 10 minutes.&#xD;
Nebulisation will be repeated 3 times, in addition, patients receive 2 ml IV SS every 5 minutes as placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High dose nebulised morphine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patient will receive 20 mg of morphine prepared with 3 ml saline serum (SS) and nebulised with 6 l/min flow during 10 minutes.&#xD;
Nebulisation will be repeated 3 times, in addition, patients receive 2 ml IV SS every 5 minutes as placebo.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IV titrated morphine</intervention_name>
    <description>Intravenous morphine : 2 mg every 5 minutes by IV root and nebulized placebo:&#xD;
SS nebulised : 5 ml SS nebulised over 10 minutes and repeated 3 times</description>
    <arm_group_label>IV titrated morphine</arm_group_label>
    <other_name>IV morphine group</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Low dose nebulised morphine</intervention_name>
    <description>10 mg morphine in 4 ml Serum Saline(SS) nebulised over 10 minutes and repeated 3 times, and SS IV placebo : 2 ml by IV root every 5 minutes</description>
    <arm_group_label>Low dose nebulised morphine</arm_group_label>
    <other_name>Neb10</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>High dose nebulised morphine</intervention_name>
    <description>20 mg morphine in 3 ml serum saline (SS) nebulised over 10 minutes and repeated 3 times, and SS IV placebo : 2 ml by IV root every 5 minutes</description>
    <arm_group_label>High dose nebulised morphine</arm_group_label>
    <other_name>Neb20</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients older than 8 years and less than 50 years&#xD;
&#xD;
          -  patients who consult emergency department for sever pain after an immediately trauma&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Glasgow coma scale &lt;14&#xD;
&#xD;
          -  inability to cooperate&#xD;
&#xD;
          -  hypotension with systolic blood pressure&lt; 90mmhg&#xD;
&#xD;
          -  bradypnea&lt;12cpm&#xD;
&#xD;
          -  SAO2&lt;90%&#xD;
&#xD;
          -  polytrauma&#xD;
&#xD;
          -  nasal trauma&#xD;
&#xD;
          -  rhinitis&#xD;
&#xD;
          -  nasal obstruction&#xD;
&#xD;
          -  allergy to opioids&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nouira Semir, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Monastir</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Emergency Department</name>
      <address>
        <city>Monastir</city>
        <zip>5000</zip>
        <country>Tunisia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Tunisia</country>
  </location_countries>
  <link>
    <url>http://www.urgencemonastir.com</url>
    <description>official department site</description>
  </link>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>November 26, 2014</last_update_submitted>
  <last_update_submitted_qc>November 26, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 2, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Monastir</investigator_affiliation>
    <investigator_full_name>Nouira</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>post traumatic pain</keyword>
  <keyword>titrated morphine</keyword>
  <keyword>nebulised morphine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Post-Traumatic Headache</mesh_term>
    <mesh_term>Headache</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>Morphine</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/NCT02200185
org study id: TIMORNEB
nct id: NCT02200185
lead sponsor: 
has dmc: Yes
The investigators test a different technique using morphine to improve pain relief in patient
      visiting the emergency department with acute trauma pain, for this we are comparing three
      different methods of morphine administration:

        -  intravenous titrated morphine

        -  low dose nebulized morphine and

        -  high dose nebulized morphine
Trauma patients are frequent in emergency department settings, and often require urgent care.

      taking care of this patients consists on taking care of their pain and then the specific
      treatment of their traumatic lesions.

      actually, the most used medicine and most efficient one in treating pain is morphine, it's
      mechanism of action is by acting on receptors located on neuronal cell membranes and inhibit
      neurotransmitter release.

      The most applied administration root of morphine is by intravenous (IV) titration or IV
      continuous perfusion, but until now, there is no clear recommendation concerning the
      superiority of this root over other administration techniques such as nebulization.

      In this study we aimed to investigate the efficiency, the feasibility and the tolerance of
      three morphine administration roots in patients with acute traumatic pain and to clarify the
      most adequate one to apply in emergency department settings.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Pain resolution
time frame: 30 minutes
description: primary end point defined by the decrease in intensity pain objectified by a decline in visual analogy pain scale greater than or equal to 50% of its initial value
measure: side effects
time frame: 30 minutes
description: secondary outcomes combine the occurrence of side effects requiring discontinuation of treatment such as: dizziness, dyspnea, cutaneous rush, vomiting, nausea and pruritus.
arm group label: IV titrated morphine
arm group type: Placebo Comparator
description: patient will receive 2 mg morphine each 5 min, associated to continuous nebulisation of saline serum (placebo).
Morphine administration is stopped when VAS becomes under 50% and treatment failure is defined as VAS > 50%, 30 minutes after the beginning of the protocol.
arm group label: Low dose nebulised morphine
arm group type: Experimental
description: patient will receive 10 mg of morphine prepared with 4 ml saline serum (SS) and nebulised with 6 l/min flow during 10 minutes.
Nebulisation will be repeated 3 times, in addition, patients receive 2 ml IV SS every 5 minutes as placebo
arm group label: High dose nebulised morphine
arm group type: Experimental
description: patient will receive 20 mg of morphine prepared with 3 ml saline serum (SS) and nebulised with 6 l/min flow during 10 minutes.
Nebulisation will be repeated 3 times, in addition, patients receive 2 ml IV SS every 5 minutes as placebo.
intervention type: Drug
intervention name: IV titrated morphine
description: Intravenous morphine : 2 mg every 5 minutes by IV root and nebulized placebo:
SS nebulised : 5 ml SS nebulised over 10 minutes and repeated 3 times
arm group label: IV titrated morphine
other name: IV morphine group
intervention type: Drug
intervention name: Low dose nebulised morphine
description: 10 mg morphine in 4 ml Serum Saline(SS) nebulised over 10 minutes and repeated 3 times, and SS IV placebo : 2 ml by IV root every 5 minutes
arm group label: Low dose nebulised morphine
other name: Neb10
intervention type: Drug
intervention name: High dose nebulised morphine
description: 20 mg morphine in 3 ml serum saline (SS) nebulised over 10 minutes and repeated 3 times, and SS IV placebo : 2 ml by IV root every 5 minutes
arm group label: High dose nebulised morphine
other name: Neb20
criteria: 
gender: All
minimum age: 8 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nouira Semir, Professor
role: Principal Investigator
affiliation: University of Monastir
facility: 
country: Tunisia
url: http://www.urgencemonastir.com
description: official department site
responsible party type: Principal Investigator
investigator affiliation: University of Monastir
investigator full name: Nouira
investigator title: Professor
mesh term: Post-Traumatic Headache
mesh term: Headache
mesh term: Acute Pain
mesh term: Morphine