<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/NCT04414800</url>
  </required_header>
  <id_info>
    <org_study_id>396828</org_study_id>
    <nct_id>NCT04414800</nct_id>
  </id_info>
  <brief_title>Intranasal Ketamine Versus Intranasal Fentanyl</brief_title>
  <official_title>Intranasal Ketamine Versus Intranasal Fentanyl on Pain Management in Isolated Traumatic Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Isfahan University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Isfahan University of Medical Sciences</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Abstract Background: Given the inadequate control of pain in patients with injury that refer&#xD;
      to the emergency departments, the rapid onset of action of intranasal administration in pain&#xD;
      management, and the avoidance of administering opioid medications, the present study aimed at&#xD;
      evaluating the effect of intranasal ketamine versus intranasal fentanyl on pain management in&#xD;
      isolated traumatic patients Materials and Methods: The current study was performed on 125&#xD;
      patients that were divided into the following three groups: control group (n = 41), 1 mg/kg&#xD;
      intranasal ketamine group (n = 40), and 1μg/kg intranasal fentanyl group (n = 44). Then pain&#xD;
      scores, HR, RR, BP, and SaO2 were recorded at baseline, 5, 10, 15, 30, and 40 minutes after&#xD;
      the intervention.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2017</start_date>
  <completion_date type="Actual">April 15, 2018</completion_date>
  <primary_completion_date type="Actual">March 20, 2018</primary_completion_date>
  <phase>Phase 3</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>Visual analogue score</measure>
    <time_frame>Change from baseline at 40 minutes</time_frame>
    <description>a scale for measuring the extent of pain relief</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Heart rate (HR)</measure>
    <time_frame>Change from baseline at 40 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure (BP)</measure>
    <time_frame>Change from baseline at 40 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory rate (RR)</measure>
    <time_frame>Change from baseline at 40 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SPO2</measure>
    <time_frame>Change from baseline at 40 minutes</time_frame>
    <description>Blood oxygen saturation</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">125</enrollment>
  <condition>Multiple Trauma</condition>
  <condition>Pain, Acute</condition>
  <arm_group>
    <arm_group_label>Control (Placebo+ Standard of Care))</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Ketamine + Standard of Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Fentanyl + Standard of Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Distilled water</description>
    <arm_group_label>Control (Placebo+ Standard of Care))</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketamine</intervention_name>
    <description>1 mg/kg intranasal ketamine</description>
    <arm_group_label>Ketamine + Standard of Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fentanyl</intervention_name>
    <description>1μg/kg intranasal fentanyl</description>
    <arm_group_label>Fentanyl + Standard of Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with acute limb trauma, aged 15-65 years, with moderate to severe pain (45&#xD;
             mm; visual analog scale (VAS)), with a GCS score of 15, with the systolic blood&#xD;
             pressure of lower than 180 mmHg, diastolic blood pressure of higher than 90 mmHg&#xD;
&#xD;
          -  lack of pregnancy&#xD;
&#xD;
          -  no history of allergy to ketamine, fentanyl (or opioids), or acetaminophen,&#xD;
&#xD;
          -  no history of liver diseases,&#xD;
&#xD;
          -  no acute or chronic structural or functional nasal obstruction diseases,&#xD;
&#xD;
          -  no history of drug or psychiatric addiction,&#xD;
&#xD;
          -  no pain medication within the past four hours,&#xD;
&#xD;
          -  no history of heart disease,&#xD;
&#xD;
          -  and the presentation of the written consent to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  a decrease in GCS score to less than or equal to 14,&#xD;
&#xD;
          -  an elevated systolic blood pressure to higher than 180 mmHg,&#xD;
&#xD;
          -  a decreased diastolic blood pressure to less than 80 mmHg,&#xD;
&#xD;
          -  inability to understand the VAS pain rating system,&#xD;
&#xD;
          -  symptoms of acute heart disease and respiratory depression (respiratory rate &lt;8 /&#xD;
             min),&#xD;
&#xD;
          -  and the patient's dissatisfaction to continue the cooperation in study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Al-Zahra University Hospital</name>
      <address>
        <city>Isfahan</city>
        <zip>8138938728</zip>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 2, 2020</last_update_submitted>
  <last_update_submitted_qc>June 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Isfahan University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Mehdi Nasr Isfahani</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Pain</mesh_term>
    <mesh_term>Multiple Trauma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fentanyl</mesh_term>
    <mesh_term>Ketamine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>It will be possible to share data if requested</ipd_description>
  </patient_data>
  <!-- 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/NCT04414800
org study id: 396828
nct id: NCT04414800
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Abstract Background: Given the inadequate control of pain in patients with injury that refer
      to the emergency departments, the rapid onset of action of intranasal administration in pain
      management, and the avoidance of administering opioid medications, the present study aimed at
      evaluating the effect of intranasal ketamine versus intranasal fentanyl on pain management in
      isolated traumatic patients Materials and Methods: The current study was performed on 125
      patients that were divided into the following three groups: control group (n = 41), 1 mg/kg
      intranasal ketamine group (n = 40), and 1μg/kg intranasal fentanyl group (n = 44). Then pain
      scores, HR, RR, BP, and SaO2 were recorded at baseline, 5, 10, 15, 30, and 40 minutes after
      the intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Visual analogue score
time frame: Change from baseline at 40 minutes
description: a scale for measuring the extent of pain relief
measure: Heart rate (HR)
time frame: Change from baseline at 40 minutes
measure: Blood pressure (BP)
time frame: Change from baseline at 40 minutes
measure: Respiratory rate (RR)
time frame: Change from baseline at 40 minutes
measure: SPO2
time frame: Change from baseline at 40 minutes
description: Blood oxygen saturation
arm group label: Control (Placebo+ Standard of Care))
arm group type: Placebo Comparator
arm group label: Ketamine + Standard of Care
arm group type: Active Comparator
arm group label: Fentanyl + Standard of Care
arm group type: Active Comparator
intervention type: Drug
intervention name: Placebo
description: Distilled water
arm group label: Control (Placebo+ Standard of Care))
intervention type: Drug
intervention name: Ketamine
description: 1 mg/kg intranasal ketamine
arm group label: Ketamine + Standard of Care
intervention type: Drug
intervention name: Fentanyl
description: 1μg/kg intranasal fentanyl
arm group label: Fentanyl + Standard of Care
criteria: 
gender: All
minimum age: 15 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Iran, Islamic Republic of
responsible party type: Principal Investigator
investigator affiliation: Isfahan University of Medical Sciences
investigator full name: Mehdi Nasr Isfahani
investigator title: Dr.
mesh term: Acute Pain
mesh term: Multiple Trauma
mesh term: Fentanyl
mesh term: Ketamine
sharing ipd: No
ipd description: It will be possible to share data if requested