Acupuncture and Nausea/Vomiting in Pediatric Patients

Postoperative Vomiting and Nausea Clinical Trial

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01417741
• Other study ID #: APOM-7605
• Status: Completed
• Phase: N/A
• Start date: August 2011
• Est. completion date: December 31, 2018

Study information

• Verified date: August 2019
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: December 31, 2018
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 9 Years

Eligibility

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

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Postoperative Vomiting and Nausea
• Vomiting

Intervention

Device:
• Acupuncture Needle
A small 1.8 mm needle to be placed in the P6 acupuncture point on the wrist

Locations

Country	Name	City	State
United States	Oregon Health and Sciences University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Martin CS, Deverman SE, Norvell DC, Cusick JC, Kendrick A, Koh J. Randomized trial of acupuncture with antiemetics for reducing postoperative nausea in children. Acta Anaesthesiol Scand. 2019 Mar;63(3):292-297. doi: 10.1111/aas.13288. Epub 2018 Nov 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Nausea and Vomiting	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	24 hours