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Acupuncture for Postoperative Nausea, Vomiting and Pain in Children: The Implication of Parental Attitudes

Primary Purpose

Postoperative Nausea and Vomiting, Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
University of Tromso
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Nausea and Vomiting focused on measuring Acupuncture, Children, Postoperative nausea and vomiting, Postoperative pain, Parental attitudes, Parental expectations

Eligibility Criteria

2 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children from two to eleven years of age
  • Children scheduled for tonsillectomy and/or adenoidectomy
  • Informed consent from the parents

Exclusion Criteria:

  • American Society of Anesthesiologists grade greater than or equal to III (patient with severe systemic disease)
  • Patients/parents in need of an interpreter
  • Rash or local infection over an acupuncture point
  • Emesis during the previous 24 hours
  • Use of medication with antiemetic effect within the 24 hours before surgery
  • Gastric or intestinal diseases

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Acupuncture and standard treatment

    Standard treatment

    Arm 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

    General anaesthesia

    Outcomes

    Primary Outcome Measures

    Postoperative nausea Postoperative vomiting Postoperative pain

    Secondary Outcome Measures

    Full Information

    First Posted
    November 13, 2012
    Last Updated
    September 18, 2013
    Sponsor
    University of Tromso
    Collaborators
    Norwegian Foundation for Health and Rehabilitation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01729052
    Brief Title
    Acupuncture for Postoperative Nausea, Vomiting and Pain in Children: The Implication of Parental Attitudes
    Official Title
    The Effect of Acupuncture for Alleviation of Postoperative Nausea, Vomiting, and Pain in Children: The Implications of Parental Attitudes and Expectations
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2012 (undefined)
    Primary Completion Date
    June 2013 (Actual)
    Study Completion Date
    June 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Tromso
    Collaborators
    Norwegian Foundation for Health and Rehabilitation

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Nausea and Vomiting, Postoperative Pain
    Keywords
    Acupuncture, Children, Postoperative nausea and vomiting, Postoperative pain, Parental attitudes, Parental expectations

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    282 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Acupuncture and standard treatment
    Arm Type
    Experimental
    Arm 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 Title
    Standard treatment
    Arm Type
    No Intervention
    Arm Description
    General anaesthesia
    Intervention Type
    Device
    Intervention Name(s)
    Acupuncture
    Primary Outcome Measure Information:
    Title
    Postoperative nausea Postoperative vomiting Postoperative pain
    Time Frame
    Within 24 hours postoperatively
    Other Pre-specified Outcome Measures:
    Title
    Parental attitudes Parental expectations
    Time Frame
    Within 24 hours postoperatively

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    11 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Children from two to eleven years of age Children scheduled for tonsillectomy and/or adenoidectomy Informed consent from the parents Exclusion Criteria: American Society of Anesthesiologists grade greater than or equal to III (patient with severe systemic disease) Patients/parents in need of an interpreter Rash or local infection over an acupuncture point Emesis during the previous 24 hours Use of medication with antiemetic effect within the 24 hours before surgery Gastric or intestinal diseases
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Arne Johan Norheim, dr.phil.
    Organizational Affiliation
    NAFKAM, UiT
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    29898710
    Citation
    Liodden I, Pripp AH, Norheim AJ. Placebo by proxy expectations toward acupuncture change over time: a survey comparing parental expectations to acupuncture pre- and postoperatively. BMC Complement Altern Med. 2018 Jun 14;18(1):183. doi: 10.1186/s12906-018-2248-z.
    Results Reference
    derived
    PubMed Identifier
    26840420
    Citation
    Liodden I, Sandvik L, Norheim AJ. Placebo by Proxy--the Influence of Parental Anxiety and Expectancy on Postoperative Morbidities in Children. Forsch Komplementmed. 2015;22(6):381-7. doi: 10.1159/000442565. Epub 2015 Dec 7.
    Results Reference
    derived
    PubMed Identifier
    25870177
    Citation
    Liodden I, Sandvik L, Valeberg BT, Borud E, Norheim AJ. Acupuncture versus usual care for postoperative nausea and vomiting in children after tonsillectomy/adenoidectomy: a pragmatic, multicentre, double-blinded, randomised trial. Acupunct Med. 2015 Jun;33(3):196-203. doi: 10.1136/acupmed-2014-010738. Epub 2015 Apr 13.
    Results Reference
    derived

    Learn more about this trial

    Acupuncture for Postoperative Nausea, Vomiting and Pain in Children: The Implication of Parental Attitudes

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