Acupuncture and Acupressure for Postoperative Nausea and Vomiting in Children Undergoing Outpatient Middle Ear Surgery
1 other identifier
interventional
11
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 5, 2017
CompletedFirst Submitted
Initial submission to the registry
November 28, 2017
CompletedFirst Posted
Study publicly available on registry
December 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 6, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 6, 2019
CompletedApril 11, 2019
April 1, 2019
1.8 years
November 28, 2017
April 9, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The evaluation of post operative nausea and vomiting at different time points during and after hospital stay.
number of emesis events
24 hours
Secondary Outcomes (4)
number of antiemetics administered during the study period,
24 hrs
time to oral intake tolerance
24 hrs
duration of recovery room stay
24 hours
nausea requiring admission to hospital, emergency room or another medical care providers
24 hrs
Study Arms (2)
Acupuncture/Acupressure Group
EXPERIMENTALBilateral 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 COMPARATORBilateral 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.
Interventions
These bands use pressure to stimulate the P6 acupuncture point.
These sham bands are used to make it seem like the band is using pressure to stimulate the P6 acupuncture point.
Eligibility Criteria
You may qualify if:
- Healthy ASA 1 and 2 Patients
- Age 2 to 18 years old
- Undergoing Outpatient Middle ear surgery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California Davis Medical Center
Sacramento, California, 95817, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 28, 2017
First Posted
December 21, 2017
Study Start
April 5, 2017
Primary Completion
February 6, 2019
Study Completion
February 6, 2019
Last Updated
April 11, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share