<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/NCT01729052</url>
  </required_header>
  <id_info>
    <org_study_id>2012/631</org_study_id>
    <nct_id>NCT01729052</nct_id>
  </id_info>
  <brief_title>Acupuncture for Postoperative Nausea, Vomiting and Pain in Children: The Implication of Parental Attitudes</brief_title>
  <official_title>The Effect of Acupuncture for Alleviation of Postoperative Nausea, Vomiting, and Pain in Children: The Implications of Parental Attitudes and Expectations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Tromso</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Norwegian Foundation for Health and Rehabilitation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Tromso</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Postoperative nausea and vomiting (PONV) remain a significant challenge in our practice.&#xD;
      However, pharmaceutical prophylaxis is only partially effective and can imply unpleasant&#xD;
      adverse effects. Accordingly, the use of non-pharmacological methods in preventing PONV is&#xD;
      appropriate. Acupuncture is reported to reduce PONV and pain, and the adverse events are&#xD;
      minimal.&#xD;
&#xD;
      The objective of this multicentre, double-blinded, randomized, controlled trial is to&#xD;
      investigate whether acupuncture can be a supplementary to the ordinary treatment in children&#xD;
      undergoing tonsillectomy and/or adenoidectomy. In addition, the non-specific effect of&#xD;
      parental attitudes and expectations on the outcomes will be explored.&#xD;
&#xD;
      Two hundred and eighty patients will be included and randomized into two groups&#xD;
&#xD;
        1. Treatment group: acupuncture treatment (approximately 15 to 20 minutes) during&#xD;
           anaesthesia and standard treatment&#xD;
&#xD;
        2. Control group: standard treatment&#xD;
&#xD;
      The primary endpoints in the intervention study are nausea, retching, vomiting and pain&#xD;
      during 24 hours postoperatively. The effect of acupuncture will be studied with regard to any&#xD;
      association with possible factors of predisposition to PONV, as well as with other factors&#xD;
      registered during the study. Adverse events from acupuncture will be registered.&#xD;
&#xD;
      The objective of the self-report questionnaires is to&#xD;
&#xD;
        -  investigate parental attitudes and expectations to the acupuncture treatment pre- and&#xD;
           postoperatively&#xD;
&#xD;
        -  compare data of the outcomes from the intervention trial with data from the&#xD;
           questionnaires, in order to find any correlation between parental beliefs, attitudes and&#xD;
           expectations, and the effect of the acupuncture treatment&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative nausea Postoperative vomiting Postoperative pain</measure>
    <time_frame>Within 24 hours postoperatively</time_frame>
  </primary_outcome>
  <other_outcome>
    <measure>Parental attitudes Parental expectations</measure>
    <time_frame>Within 24 hours postoperatively</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">282</enrollment>
  <condition>Postoperative Nausea and Vomiting</condition>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>Acupuncture and standard treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Acupuncture at Neiguan (Pericardium-6) bilaterally with Seirin needles no 3 (0.20x15 mm) to a depth of approximately 7 mm will be performed on the children immediately after induction of anaesthesia and removed before they are fully awake.&#xD;
Standard treatment: general anaesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard treatment</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>General anaesthesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Acupuncture</intervention_name>
    <arm_group_label>Acupuncture and standard treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children from two to eleven years of age&#xD;
&#xD;
          -  Children scheduled for tonsillectomy and/or adenoidectomy&#xD;
&#xD;
          -  Informed consent from the parents&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists grade greater than or equal to III (patient with&#xD;
             severe systemic disease)&#xD;
&#xD;
          -  Patients/parents in need of an interpreter&#xD;
&#xD;
          -  Rash or local infection over an acupuncture point&#xD;
&#xD;
          -  Emesis during the previous 24 hours&#xD;
&#xD;
          -  Use of medication with antiemetic effect within the 24 hours before surgery&#xD;
&#xD;
          -  Gastric or intestinal diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Arne Johan Norheim, dr.phil.</last_name>
    <role>Principal Investigator</role>
    <affiliation>NAFKAM, UiT</affiliation>
  </overall_official>
  <verification_date>September 2013</verification_date>
  <study_first_submitted>November 13, 2012</study_first_submitted>
  <study_first_submitted_qc>November 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>September 18, 2013</last_update_submitted>
  <last_update_submitted_qc>September 18, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 19, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Acupuncture</keyword>
  <keyword>Children</keyword>
  <keyword>Postoperative nausea and vomiting</keyword>
  <keyword>Postoperative pain</keyword>
  <keyword>Parental attitudes</keyword>
  <keyword>Parental expectations</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
    <mesh_term>Nausea</mesh_term>
    <mesh_term>Vomiting</mesh_term>
    <mesh_term>Postoperative Nausea and Vomiting</mesh_term>
  </condition_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/NCT01729052
org study id: 2012/631
nct id: NCT01729052
lead sponsor: 
collaborator: 
has dmc: No
Postoperative nausea and vomiting (PONV) remain a significant challenge in our practice.
      However, pharmaceutical prophylaxis is only partially effective and can imply unpleasant
      adverse effects. Accordingly, the use of non-pharmacological methods in preventing PONV is
      appropriate. Acupuncture is reported to reduce PONV and pain, and the adverse events are
      minimal.

      The objective of this multicentre, double-blinded, randomized, controlled trial is to
      investigate whether acupuncture can be a supplementary to the ordinary treatment in children
      undergoing tonsillectomy and/or adenoidectomy. In addition, the non-specific effect of
      parental attitudes and expectations on the outcomes will be explored.

      Two hundred and eighty patients will be included and randomized into two groups

        1. Treatment group: acupuncture treatment (approximately 15 to 20 minutes) during
           anaesthesia and standard treatment

        2. Control group: standard treatment

      The primary endpoints in the intervention study are nausea, retching, vomiting and pain
      during 24 hours postoperatively. The effect of acupuncture will be studied with regard to any
      association with possible factors of predisposition to PONV, as well as with other factors
      registered during the study. Adverse events from acupuncture will be registered.

      The objective of the self-report questionnaires is to

        -  investigate parental attitudes and expectations to the acupuncture treatment pre- and
           postoperatively

        -  compare data of the outcomes from the intervention trial with data from the
           questionnaires, in order to find any correlation between parental beliefs, attitudes and
           expectations, and the effect of the acupuncture treatment
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Postoperative nausea Postoperative vomiting Postoperative pain
time frame: Within 24 hours postoperatively
measure: Parental attitudes Parental expectations
time frame: Within 24 hours postoperatively
arm group label: Acupuncture and standard treatment
arm group type: Experimental
description: Acupuncture at Neiguan (Pericardium-6) bilaterally with Seirin needles no 3 (0.20x15 mm) to a depth of approximately 7 mm will be performed on the children immediately after induction of anaesthesia and removed before they are fully awake.
Standard treatment: general anaesthesia
arm group label: Standard treatment
arm group type: No Intervention
description: General anaesthesia
intervention type: Device
intervention name: Acupuncture
arm group label: Acupuncture and standard treatment
criteria: 
gender: All
minimum age: 2 Years
maximum age: 11 Years
healthy volunteers: No
last name: Arne Johan Norheim, dr.phil.
role: Principal Investigator
affiliation: NAFKAM, UiT
responsible party type: Sponsor
mesh term: Pain, Postoperative
mesh term: Nausea
mesh term: Vomiting
mesh term: Postoperative Nausea and Vomiting