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

Not Applicable

Completed

• Conditions: Nausea; Vomiting; PONV
• Interventions: Other: Acupressure Band; Other: Sham Band

• Registration Number: NCT03380182
• Lead Sponsor: University of California, Davis

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-04-05
• Study First Submitted: 2017-11-28
• Study First Submitted QC: 2017-12-15
• Study First Posted: 2017-12-21
• Primary Completion: 2019-02-06
• Study Completion: 2019-02-06
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-09
• Last Update Posted: 2019-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture/Acupressure Group	Acupressure Band	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.
Control Group	Sham Band	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

University of California Davis Medical Center; 🇺🇸 Sacramento, California, United States