NauseaNCT03380182
Acupuncture and Acupressure for Postoperative Nausea and Vomiting in Children Undergoing Outpatient Middle Ear Surgery
A study testing Acupressure Band in people with Nausea and Vomiting, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- What is being tested?
- Acupressure Band
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2017to 6 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy ASA 1 and 2 Patients
- Age 2 to 18 years old
- Undergoing Outpatient Middle ear surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Davis Medical Center
Sacramento, California, 95817
About this study
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.
Read the 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.
- Being tested
- Acupressure Band, Sham Band
- Keywords
- acupuncture, acupressure
- Medical subject headings
- Nausea, Vomiting, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupressure BandOther
These bands use pressure to stimulate the P6 acupuncture point.
Sham BandOther
These sham bands are used to make it seem like the band is using pressure to stimulate the P6 acupuncture point.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture/Acupressure Group | Experimental | 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. Receives: Other: Acupressure Band |
| Control Group | Sham comparator | 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. Receives: Other: Sham Band |
What is being measured
The primary outcome is the main question the study is designed to answer.
The evaluation of post operative nausea and vomiting at different time points during and after hospital stay.
number of emesis events
Measured: 24 hours
Secondary outcomes (4)
number of antiemetics administered during the study period,
number of antiemetics administered
Measured: 24 hrs
time to oral intake tolerance
time measured in minutes
Measured: 24 hrs
duration of recovery room stay
time measured in minutes
Measured: 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
Measured: 24 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2017
- Study start5 Apr 2017
- Primary completion6 Feb 2019
- Study completion6 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NauseaStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03380182
- Sponsor's protocol ID
- 987983
- Status last verified
- Apr 2019
- First submitted
- 28 Nov 2017
- Last updated
- 11 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture and Acupressure for Postoperative Nausea and Vomiting in Children Undergoing Outpatient Middle Ear Surgery
- ClinicalTrials.gov ID
- NCT03380182
- Acronym / sponsor ID
- 987983
- Keywords
- acupuncture, acupressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 5 Apr 2017 (actual)
- Primary completion
- 6 Feb 2019 (actual)
- Study completion
- 6 Feb 2019 (actual)
- First posted
- 21 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture/Acupressure Group | Experimental | Other: Acupressure BandBilateral 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 comparator | Other: Sham BandBilateral 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. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Healthy ASA 1 and 2 Patients
- Age 2 to 18 years old
- Undergoing Outpatient Middle ear surgery
Key exclusion criteria (8 listed)
- ASA 3 and above
- Patients with underlying pro-emetogenic disease
- Patients currently taking antiemetic agents
- pregnant women
- Cognitively impaired adults
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupressure BandThese bands use pressure to stimulate the P6 acupuncture point. | Other | Acupuncture/Acupressure Group |
| Sham BandThese sham bands are used to make it seem like the band is using pressure to stimulate the P6 acupuncture point. | Other | Control Group |
Primary outcome
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
4 secondary outcomes
number of antiemetics administered during the study period,
Time frame: 24 hrs
time to oral intake tolerance
Time frame: 24 hrs
duration of recovery room stay
Time frame: 24 hours
nausea requiring admission to hospital, emergency room or another medical care providers
Time frame: 24 hrs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupressure Band in people with Nausea and Vomiting, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The evaluation of post operative nausea and vomiting at different time points during and after hospital stay. (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2019.