Acupuncture and Acupressure for Postoperative Nausea and Vomiting in Children Undergoing Outpatient Middle Ear Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03380182|
Recruitment Status : Recruiting
First Posted : December 21, 2017
Last Update Posted : April 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Nausea Vomiting PONV||Other: Acupressure Band Other: Sham Band||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Acupuncture and Acupressure for Postoperative Nausea and Vomiting in Children Undergoing Outpatient Middle Ear Surgery|
|Actual Study Start Date :||April 5, 2017|
|Estimated Primary Completion Date :||March 14, 2019|
|Estimated Study Completion Date :||March 14, 2019|
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.
- 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
- number of antiemetics administered during the study period, [ Time Frame: 24 hrs ]number of antiemetics administered
- time to oral intake tolerance [ Time Frame: 24 hrs ]time measured in minutes
- duration of recovery room stay [ Time Frame: 24 hours ]time measured in minutes
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03380182
|Contact: Sungeun Leefirstname.lastname@example.org|
|Contact: Ana Arias, email@example.com|
|United States, California|
|University of California Davis Medical Center||Recruiting|
|Sacramento, California, United States, 95817|
|Contact: Sungeun Lee 916-734-5028 firstname.lastname@example.org|
|Contact: Ana Arias 916-703-5456 email@example.com|
|Principal Investigator: Sungeun Lee, MD|