N/A N=161 Randomized Quadruple-blind Supportive Care

Acupuncture and Nausea/Vomiting in Pediatric Patients

Postoperative Vomiting and Nausea

Bottom Line

View on ClinicalTrials.gov: NCT01417741 ↗

Enrolled (actual)

161

Serious AEs

0.0%

Results posted

Aug 2019

Primary outcome: Primary: Postoperative Nausea and Vomiting — 26; 6; 37; 31 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Acupuncture Needle (Device)
Age: Pediatric · 3+ yrs
Sex: All
Sponsor: Oregon Health and Science University
Primary completion: Aug 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Postoperative Nausea and Vomiting	26; 6; 37; 31	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01417741). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.