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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03380182

Enrollment

Registered

2017-12-21

Start date

2017-04-05

Completion date

2019-02-06

Last updated

2019-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nausea, PONV, Vomiting

Keywords

acupuncture, acupressure

Brief summary

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.

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.

Interventions

OTHERAcupressure Band

These bands use pressure to stimulate the P6 acupuncture point.

OTHERSham Band

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

2 Years to 18 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026