<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/NCT02197546</url>
  </required_header>
  <id_info>
    <org_study_id>BB 57/10</org_study_id>
    <secondary_id>BB 57/10</secondary_id>
    <nct_id>NCT02197546</nct_id>
  </id_info>
  <brief_title>Acupuncture for Pain During Injection of Local Anaesthetic</brief_title>
  <acronym>AcuDent</acronym>
  <official_title>Acupuncture Reduces Pain and Autonomous Distress During Injection of Local Anaesthetic in Children - a Randomised Crossover Investigation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Medicine Greifswald</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Medicine Greifswald</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Stimulation of acupoint LI4 has been shown to result in analgesic effects in patients&#xD;
      experiencing acute pain. We aimed to determine whether LI4 acupuncture could reduce pain and&#xD;
      distress in children receiving an injection of a local anaesthetic (LA). Children scheduled&#xD;
      for dental treatment using local anesthesia as a standard treatment, received bilateral&#xD;
      acupuncture at LI4 using indwelling fixed needles. During the treatment, the parents of the&#xD;
      patients stimulated the needles by massage. Two different treatment regimes were compared: a&#xD;
      standardized LA injection given 5 minutes after acupuncture, and an LA injection without&#xD;
      acupuncture. The order of treatment was randomised, with the two treatments performed on&#xD;
      different days. Pain intensity during LA injection, assessed by the patient with the Verbal&#xD;
      Rating Scale or Faces Pain Scale (0-10), was used as the primary endpoint. Parent- and&#xD;
      dentist-assessed pain intensity and agitation, heart rate, and the patients' satisfaction&#xD;
      with the received therapy were also recorded.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2010</start_date>
  <completion_date type="Actual">November 2011</completion_date>
  <primary_completion_date type="Actual">June 2011</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pain intensity</measure>
    <time_frame>3 time points during one day of investigation</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>pain intensity assessed by the parents and by physicians</measure>
    <time_frame>4 time points during one day of investigation</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>heart rate</measure>
    <time_frame>5 time points during one days of investigation</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">49</enrollment>
  <condition>Pain</condition>
  <condition>Distress</condition>
  <condition>Satisfaction</condition>
  <arm_group>
    <arm_group_label>acupuncture plus local anesthesia</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Bilateral acupuncture with 1.5 mm long indwelling fixed needles</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Local anesthesia alone</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard therapy - local anesthesia alone without acupuncture</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Acupuncture &amp; acupressure</intervention_name>
    <description>Bilateral acupuncture with indwelling fixed needles 1.5 mm length with subsequent acupressure by the parents</description>
    <arm_group_label>acupuncture plus local anesthesia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  children with an American Society of Anesthesiologists (ASA) physical status of I or&#xD;
             II&#xD;
&#xD;
          -  scheduled for at least two dental treatments for caries requiring local anaesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of analgesic medication, psychiatric disease, or local or systemic infection&#xD;
&#xD;
          -  necessity to change their treatment schedule&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christian Splieth, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University Medicine of Greifswald</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Medicine of Greifswald</name>
      <address>
        <city>Greifswald</city>
        <zip>17475</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 21, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>July 21, 2014</last_update_submitted>
  <last_update_submitted_qc>July 21, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 22, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Injection pain</keyword>
  <keyword>local anesthesia</keyword>
  <keyword>acupuncture</keyword>
  <!-- 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/NCT02197546
org study id: BB 57/10
secondary id: BB 57/10
nct id: NCT02197546
lead sponsor: 
has dmc: No
Stimulation of acupoint LI4 has been shown to result in analgesic effects in patients
      experiencing acute pain. We aimed to determine whether LI4 acupuncture could reduce pain and
      distress in children receiving an injection of a local anaesthetic (LA). Children scheduled
      for dental treatment using local anesthesia as a standard treatment, received bilateral
      acupuncture at LI4 using indwelling fixed needles. During the treatment, the parents of the
      patients stimulated the needles by massage. Two different treatment regimes were compared: a
      standardized LA injection given 5 minutes after acupuncture, and an LA injection without
      acupuncture. The order of treatment was randomised, with the two treatments performed on
      different days. Pain intensity during LA injection, assessed by the patient with the Verbal
      Rating Scale or Faces Pain Scale (0-10), was used as the primary endpoint. Parent- and
      dentist-assessed pain intensity and agitation, heart rate, and the patients' satisfaction
      with the received therapy were also recorded.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: pain intensity
time frame: 3 time points during one day of investigation
measure: pain intensity assessed by the parents and by physicians
time frame: 4 time points during one day of investigation
measure: heart rate
time frame: 5 time points during one days of investigation
arm group label: acupuncture plus local anesthesia
arm group type: Other
description: Bilateral acupuncture with 1.5 mm long indwelling fixed needles
arm group label: Local anesthesia alone
arm group type: No Intervention
description: Standard therapy - local anesthesia alone without acupuncture
intervention type: Other
intervention name: Acupuncture & acupressure
description: Bilateral acupuncture with indwelling fixed needles 1.5 mm length with subsequent acupressure by the parents
arm group label: acupuncture plus local anesthesia
criteria: 
gender: All
minimum age: 4 Years
maximum age: 17 Years
healthy volunteers: No
last name: Christian Splieth, MD, PhD
role: Study Chair
affiliation: University Medicine of Greifswald
facility: 
country: Germany
responsible party type: Sponsor