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Acupuncture and Nausea/Vomiting in Pediatric Patients

Primary Purpose

Postoperative Vomiting and Nausea

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Acupuncture Needle

About this trial

This is an interventional supportive care trial for Postoperative Vomiting and Nausea

Eligibility Criteria

3 Years - 9 Years (Child)All SexesDoes not accept 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

Sites / Locations

Oregon Health and Sciences University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard Therapy Only

Acupuncture Plus Standard Therapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01417741

First Posted

August 15, 2011

Last Updated

August 9, 2019

Sponsor

Oregon Health and Science University

1. Study Identification

Unique Protocol Identification Number

NCT01417741

Brief Title

Acupuncture and Nausea/Vomiting in Pediatric Patients

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?

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

August 2011 (Actual)

Primary Completion Date

August 2014 (Actual)

Study Completion Date

December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Oregon Health and Science University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Vomiting and Nausea

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

164 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard Therapy Only

Arm Type

No Intervention

Arm Description

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

Arm Title

Acupuncture Plus Standard Therapy

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Acupuncture Needle

Other Intervention Name(s)

Seirin Pyonex

Intervention Description

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

Primary Outcome Measure Information:

Title

Postoperative Nausea and Vomiting

Description

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

9 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Angela Kendrick, MD

Organizational Affiliation

Oregon Health and Science University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Christine Martin, MD

Organizational Affiliation

Oregon Health and Science University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Oregon Health and Sciences University

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30397904

Citation

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.

Results Reference

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Acupuncture and Nausea/Vomiting in Pediatric Patients

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