Acupuncture and Nausea/Vomiting in Pediatric Patients

NCT01417741 | Completed Results DMC

• 1 other identifier: APOM-7605
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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. 1.Treatment Group: Standard anti-emetic therapy plus bilateral P6 acupuncture after the induction of anesthesia
2. 2.Control Group: Standard anti-emetic therapy only

Conditions

Postoperative Vomiting and Nausea

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Standard Therapy Only

NO INTERVENTION

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

Acupuncture Plus Standard Therapy

EXPERIMENTAL

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

Device: Acupuncture Needle

Interventions

Acupuncture Needle DEVICE

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

Also known as: Seirin Pyonex

Acupuncture Plus Standard Therapy

Eligibility Criteria

• Age: 3 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ASA 1 to 3 physical status
• Undergoing Tonsillectomy and/or adenoidectomy
• Consent obtained from Parent/Guardian

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health and Sciences University

Portland, Oregon, 97239, United States

Location

Related 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.

  PMID: 30397904 BACKGROUND

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Christine Martin, assistant professor
• Organization: OHSU department of APOM

martich@ohsu.edu

503 494 7641

Study Officials

• Angela Kendrick, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

• Christine Martin, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: August 15, 2011
• First Posted: August 16, 2011
• Study Start: August 1, 2011
• Primary Completion: August 1, 2014
• Study Completion: December 31, 2018
• Last Updated: August 28, 2019
• Results First Posted: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)