Acupuncture and Nausea/Vomiting in Pediatric Patients

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.

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Key information

Conditions

Postoperative Vomiting and Nausea Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

3 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health and Sciences University

Portland, Oregon, 97239, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acupuncture Needle

Device

A small 1.8 mm needle to be placed in the P6 acupuncture point on the wrist

Other names: Seirin Pyonex

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study 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?

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2018
First posted: Aug 16, 2011
Registry last updated: Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed