Acupuncture and Acupressure for Postoperative Nausea and Vomiting in Children Undergoing Outpatient Middle Ear Surgery

April 9, 2019 updated by: University of California, Davis
The specific aim of this study is to determine the incidence of post-operative nausea and vomiting (PONV) in the pediatric population undergoing outpatient middle ear surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The specific aim of this study is to determine the incidence of post-operative nausea and vomiting (PONV) in the pediatric population undergoing outpatient middle ear surgery receiving our institution's standard dual prophylactic antiemetic therapy in combination with intraoperative acupuncture and postoperative acupressure compared to those receiving only the standard dual prophylactic antiemetic therapy.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • University of California Davis Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy ASA 1 and 2 Patients
  • Age 2 to 18 years old
  • Undergoing Outpatient Middle ear surgery

Exclusion Criteria:

  • ASA 3 and above
  • Patients with underlying pro-emetogenic disease
  • Patients currently taking antiemetic agents
  • pregnant women
  • Cognitively impaired adults
  • prisoners
  • History of bleeding disorder
  • Age less than 2 or greater than 18

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acupuncture/Acupressure Group
Bilateral P6 point acupuncture will be performed intra-operatively by the PI, who has UC Davis Medical Center privilege for this specific acupuncture, while the patient is under anesthesia. Patient will be sent home with an acupressure band, which is to remain on for 24 hours post operatively.
Other: Acupressure Band
These bands use pressure to stimulate the P6 acupuncture point.
Sham Comparator: Control Group
Bilateral sham point acupuncture will be performed intra-operatively. Patient will be sent home with a wrist sham band matching in appearance of acupressure bands without the acupressure function, which is to remain on for 24 hours post operatively.
Other: Sham Band
These sham bands are used to make it seem like the band is using pressure to stimulate the P6 acupuncture point.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The evaluation of post operative nausea and vomiting at different time points during and after hospital stay.
Time Frame: 24 hours
number of emesis events
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of antiemetics administered during the study period,
Time Frame: 24 hrs
number of antiemetics administered
24 hrs
time to oral intake tolerance
Time Frame: 24 hrs
time measured in minutes
24 hrs
duration of recovery room stay
Time Frame: 24 hours
time measured in minutes
24 hours
nausea requiring admission to hospital, emergency room or another medical care providers
Time Frame: 24 hrs
Desc: number of events requiring ER visit, hospitalization or care from another medical care provider
24 hrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2017

Primary Completion (Actual)

February 6, 2019

Study Completion (Actual)

February 6, 2019

Study Registration Dates

First Submitted

November 28, 2017

First Submitted That Met QC Criteria

December 15, 2017

First Posted (Actual)

December 21, 2017

Study Record Updates

Last Update Posted (Actual)

April 11, 2019

Last Update Submitted That Met QC Criteria

April 9, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 987983

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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