Skip to main content
OpenTrials
Completed

NCT Number: NCT03380182

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California Davis Medical Center

Sacramento, California, 95817, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acupressure Band

Other

These bands use pressure to stimulate the P6 acupuncture point.

Sham Band

Other

These sham bands are used to make it seem like the band is using pressure to stimulate the P6 acupuncture point.

Primary outcomes

  1. 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

Secondary outcomes

  1. number of antiemetics administered during the study period,

    Time frame: 24 hrs

    number of antiemetics administered

  2. time to oral intake tolerance

    Time frame: 24 hrs

    time measured in minutes

  3. duration of recovery room stay

    Time frame: 24 hours

    time measured in minutes

  4. 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

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 21, 2017
Registry last updated
Apr 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.