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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Nausea, Vomiting, PONV

Intervention / Treatment
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* Other: Acupressure Band
* Other: Sham Band


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture/Acupressure Group<br>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<br>* These bands use pressure to stimulate the P6 acupuncture point.<br>|
| Sham Comparator: Control Group<br>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<br>* These sham bands are used to make it seem like the band is using pressure to stimulate the P6 acupuncture point.<br>|

What is the study measuring?
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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. | number of emesis events | 24 hours | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acupuncture, acupressure