<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/NCT04426409</url>
  </required_header>
  <id_info>
    <org_study_id>AJIRB-MED-INT-19-508</org_study_id>
    <nct_id>NCT04426409</nct_id>
  </id_info>
  <brief_title>Nasal Ointment on Epistaxis of Nasotracheal Intubation in Children</brief_title>
  <official_title>Effect of Nasal Ointment on Epistaxis of Nasotracheal Intubation in Children: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ajou University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ajou University School of Medicine</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>
      Nasotracheal intubation is one of the anesthetic procedures required for oral surgery. It&#xD;
      allows the surgeon easier access to the surgical site than the orthotracheal intubation.&#xD;
      Therefore, nosotracheal intubation is commonly used for general anesthesia for oral and&#xD;
      maxillofacial surgery and dental treatment. However, nasotracheal intubation can damage the&#xD;
      nasal mucosa in the course of the tube passing through the nostrils, causing epistaxis which&#xD;
      is reported as the most common side effect.&#xD;
&#xD;
      In order to reduce these side effects, heating of the tube and use of a tube lubricant&#xD;
      immediately before intubation have been recommended in children. However, research on whether&#xD;
      the dry state of the mucosa itself contributes to the development of epistaxis is limited. A&#xD;
      study in adults reported that pretreatment of the ointment on the mucosa reduced the damage&#xD;
      to the mucosa. However, its effect on the incidence of epistaxis in children has not been&#xD;
      studied.&#xD;
&#xD;
      The purpose of this study is to investigate the effects of pretreatment of nasal ointment on&#xD;
      epistaxis of nasotracheal intubation in children.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 8, 2020</start_date>
  <completion_date type="Actual">September 1, 2021</completion_date>
  <primary_completion_date type="Actual">September 1, 2021</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>Prevention</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>incidence of epistaxis</measure>
    <time_frame>immediate after intubation</time_frame>
    <description>percentage of the development of epistaxis after nasotracheal intubation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>incidence of epistaxis</measure>
    <time_frame>immediate after extubation</time_frame>
    <description>percentage of the development of epistaxis after nasotracheal intubation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>severity of epistaxis</measure>
    <time_frame>immediate after intubation</time_frame>
    <description>score based on severity of epistaxis will be recorded.&#xD;
1: no epistaxis, 2: mild; blood on tube 3. moderate: blood pooling on pharynx 4. severe: interfere intubation by blood</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>severity of epistaxis</measure>
    <time_frame>immediate after extubation</time_frame>
    <description>score based on severity of epistaxis will be recorded.&#xD;
1: no epistaxis, 2: mild; blood on tube 3. moderate: blood pooling on pharynx 4. severe: interfere intubation by blood</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Navigability</measure>
    <time_frame>immediate after intubation</time_frame>
    <description>score based on easiness of navigation during intubation&#xD;
1. No resistance 2. Pass with some resistance(1try, mild) 3. Pass with some resistance (&gt;=2) 4. Failed to pass (Try to another nose) 5. Failed to pass both nostril (use more smaller tube)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">108</enrollment>
  <condition>Epistaxis</condition>
  <condition>Intubation</condition>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>ointment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ointment group should apply a nasal ointment to both noses using a cotton swab the night before surgery and the morning of surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>tarivid ointment</intervention_name>
    <description>Vaseline ointment is applied to both noses.</description>
    <arm_group_label>ointment group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists physical statue I or II&#xD;
&#xD;
          -  Patients scheduled to undergo surgery under nasotracheal intubation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  expected difficult intubation based on history, physical examination, weight.&#xD;
&#xD;
          -  bleeding tendency&#xD;
&#xD;
          -  upper respiratory infection within the previous 14 days&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ajou University School of Medicine</name>
      <address>
        <city>Suwon</city>
        <state>Gyeong-gi</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>July 24, 2022</last_update_submitted>
  <last_update_submitted_qc>July 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ajou University School of Medicine</investigator_affiliation>
    <investigator_full_name>yun jeong chae</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epistaxis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ofloxacin</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/NCT04426409
org study id: AJIRB-MED-INT-19-508
nct id: NCT04426409
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Nasotracheal intubation is one of the anesthetic procedures required for oral surgery. It
      allows the surgeon easier access to the surgical site than the orthotracheal intubation.
      Therefore, nosotracheal intubation is commonly used for general anesthesia for oral and
      maxillofacial surgery and dental treatment. However, nasotracheal intubation can damage the
      nasal mucosa in the course of the tube passing through the nostrils, causing epistaxis which
      is reported as the most common side effect.

      In order to reduce these side effects, heating of the tube and use of a tube lubricant
      immediately before intubation have been recommended in children. However, research on whether
      the dry state of the mucosa itself contributes to the development of epistaxis is limited. A
      study in adults reported that pretreatment of the ointment on the mucosa reduced the damage
      to the mucosa. However, its effect on the incidence of epistaxis in children has not been
      studied.

      The purpose of this study is to investigate the effects of pretreatment of nasal ointment on
      epistaxis of nasotracheal intubation in children.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Investigator, Outcomes Assessor)
measure: incidence of epistaxis
time frame: immediate after intubation
description: percentage of the development of epistaxis after nasotracheal intubation
measure: incidence of epistaxis
time frame: immediate after extubation
description: percentage of the development of epistaxis after nasotracheal intubation
measure: severity of epistaxis
time frame: immediate after intubation
description: score based on severity of epistaxis will be recorded.
1: no epistaxis, 2: mild; blood on tube 3. moderate: blood pooling on pharynx 4. severe: interfere intubation by blood
measure: severity of epistaxis
time frame: immediate after extubation
description: score based on severity of epistaxis will be recorded.
1: no epistaxis, 2: mild; blood on tube 3. moderate: blood pooling on pharynx 4. severe: interfere intubation by blood
measure: Navigability
time frame: immediate after intubation
description: score based on easiness of navigation during intubation
1. No resistance 2. Pass with some resistance(1try, mild) 3. Pass with some resistance (>=2) 4. Failed to pass (Try to another nose) 5. Failed to pass both nostril (use more smaller tube)
arm group label: control group
arm group type: No Intervention
arm group label: ointment group
arm group type: Experimental
description: Ointment group should apply a nasal ointment to both noses using a cotton swab the night before surgery and the morning of surgery.
intervention type: Drug
intervention name: tarivid ointment
description: Vaseline ointment is applied to both noses.
arm group label: ointment group
criteria: 
gender: All
minimum age: 4 Years
maximum age: 8 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Ajou University School of Medicine
investigator full name: yun jeong chae
investigator title: Professor
mesh term: Epistaxis
mesh term: Ofloxacin