Back to resultsAcupuncture and Acupressure for Postoperative Nausea and Vomiting in Children Undergoing Outpatient Middle Ear Surgery
Primary Purpose
Nausea, Vomiting, PONV
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acupressure Band
Sham Band
Sponsored by
About this trial
This is an interventional treatment trial for Nausea focused on measuring acupuncture, acupressure
Eligibility Criteria
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
Sites / Locations
- University of California Davis Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Acupuncture/Acupressure Group
Control Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
The evaluation of post operative nausea and vomiting at different time points during and after hospital stay.
number of emesis events
Secondary Outcome Measures
number of antiemetics administered during the study period,
number of antiemetics administered
time to oral intake tolerance
time measured in minutes
duration of recovery room stay
time measured in minutes
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
Full Information
NCT ID
NCT03380182
First Posted
November 28, 2017
Last Updated
April 9, 2019
Sponsor
University of California, Davis
1. Study Identification
Unique Protocol Identification Number
NCT03380182
Brief Title
Acupuncture and Acupressure for Postoperative Nausea and Vomiting in Children Undergoing Outpatient Middle Ear Surgery
Official Title
Acupuncture and Acupressure for Postoperative Nausea and Vomiting in Children Undergoing Outpatient Middle Ear Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
April 5, 2017 (Actual)
Primary Completion Date
February 6, 2019 (Actual)
Study Completion Date
February 6, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea, Vomiting, PONV
Keywords
acupuncture, acupressure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture/Acupressure Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Acupressure Band
Intervention Description
These bands use pressure to stimulate the P6 acupuncture point.
Intervention Type
Other
Intervention Name(s)
Sham Band
Intervention Description
These sham bands are used to make it seem like the band is using pressure to stimulate the P6 acupuncture point.
Primary Outcome Measure Information:
Title
The evaluation of post operative nausea and vomiting at different time points during and after hospital stay.
Description
number of emesis events
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
number of antiemetics administered during the study period,
Description
number of antiemetics administered
Time Frame
24 hrs
Title
time to oral intake tolerance
Description
time measured in minutes
Time Frame
24 hrs
Title
duration of recovery room stay
Description
time measured in minutes
Time Frame
24 hours
Title
nausea requiring admission to hospital, emergency room or another medical care providers
Description
Desc: number of events requiring ER visit, hospitalization or care from another medical care provider
Time Frame
24 hrs
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
University of California Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Acupuncture and Acupressure for Postoperative Nausea and Vomiting in Children Undergoing Outpatient Middle Ear Surgery
We'll reach out to this number within 24 hrs