Acupuncture and Nausea/Vomiting in Pediatric Patients

Not Applicable

Completed

• Conditions: Postoperative Vomiting and Nausea
• Interventions: Device: Acupuncture Needle

• Registration Number: NCT01417741
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-15
• Study First Submitted QC: 2011-08-15
• Study First Posted: 2011-08-16
• Primary Completion: 2014-08
• Study Completion: 2018-12-31
• Results First Submitted: 2019-06-25
• Status Verified: 2019-08
• Results First Submitted QC: 2019-08-09
• Last Update Submitted: 2019-08-09
• Results First Posted: 2019-08-28
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture Plus Standard Therapy	Acupuncture Needle	Bilateral P6 acupuncture applied after anesthesia induction and removed at the termination of the surgery. Patients will also receive standard anti-emetic therapy.

Primary Outcome Measures

Name	Time	Method
Postoperative Nausea and Vomiting	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

Trial Locations

Locations (1)

Oregon Health and Sciences University; 🇺🇸 Portland, Oregon, United States