Acupuncture and Nausea/Vomiting in Pediatric Patients

Oregon Health & Science University (OHSU)

Status: Completed

Conditions: Postoperative Vomiting and Nausea

Treatments: Device: Acupuncture Needle

Study type: Interventional

Funder types: Other

Identifiers

NCT01417741

APOM-7605

Details and patient eligibility

About

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.

Enrollment: 164 patients

Sex: All

Ages: 3 to 9 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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164 participants in 2 patient groups

Standard Therapy Only

No Intervention group

Description:

Patients will not receive acupuncture. Standard anti-emetic therapy will be given.

Acupuncture Plus Standard Therapy

Experimental group

Description:

Bilateral P6 acupuncture applied after anesthesia induction and removed at the termination of the surgery. Patients will also receive standard anti-emetic therapy.

Treatment:

Device: Acupuncture Needle