Acupuncture and Nausea/Vomiting in Pediatric Patients

Overview

The purpose of this study is to investigate the effects of intraoperative P6 acupuncture plus standard therapy on postoperative nausea and vomiting in pediatric patients undergoing tonsillectomy with or without adenoidectomy. 200 children will be randomly assigned to either the treatment or the control group. 1. Treatment Group: Standard anti-emetic therapy plus bilateral P6 acupuncture after the induction of anesthesia 2. Control Group: Standard anti-emetic therapy only This study will monitor nausea, retching, and vomiting events both directly after the surgery as well as the next day via a follow-up phone call to the parents of the study participant.

Full Title of Study: “Is Intra-operative Acupuncture at P6 Plus IV Antiemetics More Effective Than IV Antiemetic Therapy Alone in Preventing Postoperative Vomiting in Pediatric Patients Following Tonsillectomy With or Without Adenoidectomy?”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 2014

Interventions

  • Device: Acupuncture Needle
    • A small 1.8 mm needle to be placed in the P6 acupuncture point on the wrist

Arms, Groups and Cohorts

  • No Intervention: Standard Therapy Only
    • Patients will not receive acupuncture. Standard anti-emetic therapy will be given.
  • Experimental: Acupuncture Plus Standard Therapy
    • Bilateral P6 acupuncture applied after anesthesia induction and removed at the termination of the surgery. Patients will also receive standard anti-emetic therapy.

Clinical Trial Outcome Measures

Primary Measures

  • Postoperative Nausea and Vomiting
    • Time Frame: 24 hours
    • Post operative Nausea and vomiting in phase 1 and 11 recovery (Measured as a percentage of participants who experienced this outcome) Post op Nausea and vomiting on post op day one ( measured as a percentage of participants who experienced this outcome) as reported on a telephone survey

Participating in This Clinical Trial

Inclusion Criteria

  • ASA 1 to 3 physical status – Undergoing Tonsillectomy and/or adenoidectomy – Consent obtained from Parent/Guardian Exclusion Criteria:

  • Taking preoperative steroids, including inhalers – Taking baseline anti-emetics – History of motion sickness – BMI > 35 (morbid obesity) – Severe OSA (Apnea/hypopnea Index > 10) – Have genetic abnormalities

Gender Eligibility: All

Minimum Age: 3 Years

Maximum Age: 9 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Oregon Health and Science University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Angela Kendrick, associate professor – Oregon Health and Science University
  • Overall Official(s)
    • Angela Kendrick, MD, Principal Investigator, Oregon Health and Science University
    • Christine Martin, MD, Principal Investigator, Oregon Health and Science University

References

Martin CS, Deverman SE, Norvell DC, Cusick JC, Kendrick A, Koh J. Randomized trial of acupuncture with antiemetics for reducing postoperative nausea in children. Acta Anaesthesiol Scand. 2019 Mar;63(3):292-297. doi: 10.1111/aas.13288. Epub 2018 Nov 6.

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