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Acupuncture and Nausea/Vomiting in Pediatric Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2014 by Angela Kendrick, Oregon Health and Science University.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Angela Kendrick, Oregon Health and Science University Identifier:
First received: August 15, 2011
Last updated: April 9, 2014
Last verified: April 2014

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 Intervention
Postoperative Vomiting and Nausea Device: Acupuncture Needle

Study Type: Interventional
Study Design: 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?

Resource links provided by NLM:

Further study details as provided by Angela Kendrick, Oregon Health and Science University:

Primary Outcome Measures:
  • Postoperative Nausea and Vomiting [ Time Frame: 24 hours ]

Estimated Enrollment: 200
Study Start Date: August 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01417741

Contact: Angela Kendrick, MD 503-494-4919

United States, Oregon
Oregon Health and Sciences University Recruiting
Portland, Oregon, United States, 97239
Contact: Angela Kendrick, MD    503-494-4919   
Principal Investigator: Angela Kendrick, MD         
Sponsors and Collaborators
Oregon Health and Science University
Principal Investigator: Angela Kendrick, MD Oregon Health and Science University
  More Information

Responsible Party: Angela Kendrick, associate professor, Oregon Health and Science University Identifier: NCT01417741     History of Changes
Other Study ID Numbers: APOM-7605
Study First Received: August 15, 2011
Last Updated: April 9, 2014

Additional relevant MeSH terms:
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes processed this record on September 20, 2017