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Acupuncture and Nausea/Vomiting in Pediatric Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01417741
Recruitment Status : Completed
First Posted : August 16, 2011
Results First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Information provided by (Responsible Party):
Angela Kendrick, Oregon Health and Science University

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Postoperative Vomiting and Nausea Device: Acupuncture Needle Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: 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?
Actual Study Start Date : August 2011
Actual Primary Completion Date : August 2014
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.
Device: Acupuncture Needle
A small 1.8 mm needle to be placed in the P6 acupuncture point on the wrist
Other Name: Seirin Pyonex

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   3 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01417741

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United States, Oregon
Oregon Health and Sciences University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
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Principal Investigator: Angela Kendrick, MD Oregon Health and Science University
Principal Investigator: Christine Martin, MD Oregon Health and Science University
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Responsible Party: Angela Kendrick, associate professor, Oregon Health and Science University Identifier: NCT01417741    
Other Study ID Numbers: APOM-7605
First Posted: August 16, 2011    Key Record Dates
Results First Posted: August 28, 2019
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Postoperative Complications
Pathologic Processes