Postoperative Vomiting and NauseaNCT01417741
Acupuncture and Nausea/Vomiting in Pediatric Patients
A study testing Acupuncture Needle in people with Postoperative Vomiting and Nausea, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The purpose of this study is to investigate the effects of intraoperative P6 acupuncture plus standard therapy on postoperative nausea and vomiting in pediatric patients undergoing tonsillectomy with or without adenoidectomy. 200 children will be randomly assigned to either the treatment or the control group. 1. Read more about this study
- Who is it for?
- Ages 3 to 9 years
- Conditions the study is for
- Postoperative Vomiting and Nausea
- What is being tested?
- Acupuncture Needle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 3 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA 1 to 3 physical status
- Undergoing Tonsillectomy and/or adenoidectomy
- Consent obtained from Parent/Guardian
Who cannot join
- Taking preoperative steroids, including inhalers
- Taking baseline anti-emetics
- History of motion sickness
- BMI > 35 (morbid obesity)
- Severe OSA (Apnea/hypopnea Index > 10)
- Have genetic abnormalities
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Sciences University
Portland, Oregon, 97239
About this study
Official title: Is Intra-operative Acupuncture at P6 Plus IV Antiemetics More Effective Than IV Antiemetic Therapy Alone in Preventing Postoperative Vomiting in Pediatric Patients Following Tonsillectomy With or Without Adenoidectomy?
The purpose of this study is to investigate the effects of intraoperative P6 acupuncture plus standard therapy on postoperative nausea and vomiting in pediatric patients undergoing tonsillectomy with or without adenoidectomy. 200 children will be randomly assigned to either the treatment or the control group.
- Treatment Group: Standard anti-emetic therapy plus bilateral P6 acupuncture after the induction of anesthesia
- Control Group: Standard anti-emetic therapy only
This study will monitor nausea, retching, and vomiting events both directly after the surgery as well as the next day via a follow-up phone call to the parents of the study participant.
- Conditions
- Postoperative Vomiting and Nausea
- Being tested
- Acupuncture Needle
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture NeedleDevice
Also called Seirin Pyonex
A small 1.8 mm needle to be placed in the P6 acupuncture point on the wrist
| Study group | Role | What they receive |
|---|---|---|
| Standard Therapy Only | No intervention | Patients will not receive acupuncture. Standard anti-emetic therapy will be given. |
| Acupuncture Plus Standard Therapy | Experimental | Bilateral P6 acupuncture applied after anesthesia induction and removed at the termination of the surgery. Patients will also receive standard anti-emetic therapy. Receives: Device: Acupuncture Needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Nausea and Vomiting
Post operative Nausea and vomiting in phase 1 and 11 recovery (Measured as a percentage of participants who experienced this outcome) Post op Nausea and vomiting on post op day one ( measured as a percentage of participants who experienced this outcome) as reported on a telephone survey
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionAug 2014
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Vomiting and NauseaStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Kendrick, Oregon Health and Science University
- Investigators
- Angela Kendrick, MD, Principal investigator, Oregon Health and Science UniversityChristine Martin, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01417741
- Sponsor's protocol ID
- APOM-7605
- Status last verified
- Aug 2019
- First submitted
- 15 Aug 2011
- Last updated
- 28 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Martin CS, Deverman SE, Norvell DC, Cusick JC, Kendrick A, Koh J. Randomized trial of acupuncture with antiemetics for reducing postoperative nausea in children. Acta Anaesthesiol Scand. 2019 Mar;63(3):292-297. doi: 10.1111/aas.13288. Epub 2018 Nov 6.
PubMed 30397904
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Intra-operative Acupuncture at P6 Plus IV Antiemetics More Effective Than IV Antiemetic Therapy Alone in Preventing Postoperative Vomiting in Pediatric Patients Following Tonsillectomy With or Without Adenoidectomy?
- ClinicalTrials.gov ID
- NCT01417741
- Acronym / sponsor ID
- APOM-7605
- Conditions
- Postoperative Vomiting and Nausea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Aug 2011 (actual)
- Primary completion
- Aug 2014 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 16 Aug 2011 (estimated)
- Results
- Posted 28 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the effects of intraoperative P6 acupuncture plus standard therapy on postoperative nausea and vomiting in pediatric patients undergoing tonsillectomy with or without adenoidectomy. 200 children will be randomly assigned to either the treatment or the control group.
- Treatment Group: Standard anti-emetic therapy plus bilateral P6 acupuncture after the induction of anesthesia
- Control Group: Standard anti-emetic therapy only
This study will monitor nausea, retching, and vomiting events both directly after the surgery as well as the next day via a follow-up phone call to the parents of the study participant.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Therapy Only | No intervention | –Patients will not receive acupuncture. Standard anti-emetic therapy will be given. |
| Acupuncture Plus Standard Therapy | Experimental | Device: Acupuncture NeedleBilateral P6 acupuncture applied after anesthesia induction and removed at the termination of the surgery. Patients will also receive standard anti-emetic therapy. |
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ASA 1 to 3 physical status
- Undergoing Tonsillectomy and/or adenoidectomy
- Consent obtained from Parent/Guardian
Key exclusion criteria (6 listed)
- Taking preoperative steroids, including inhalers
- Taking baseline anti-emetics
- History of motion sickness
- BMI > 35 (morbid obesity)
- Severe OSA (Apnea/hypopnea Index > 10)
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 |
|---|---|---|
| Acupuncture NeedleAlso: Seirin PyonexA small 1.8 mm needle to be placed in the P6 acupuncture point on the wrist | Device | Acupuncture Plus Standard Therapy |
Primary outcome
Postoperative Nausea and Vomiting
Time frame: 24 hours
Post operative Nausea and vomiting in phase 1 and 11 recovery (Measured as a percentage of participants who experienced this outcome) Post op Nausea and vomiting on post op day one ( measured as a percentage of participants who experienced this outcome) as reported on a telephone survey
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30397904Martin CS, Deverman SE, Norvell DC, Cusick JC, Kendrick A, Koh J. Randomized trial of acupuncture with antiemetics for reducing postoperative nausea in children. Acta Anaesthesiol Scand. 2019 Mar;63(3):292-297. doi: 10.1111/aas.13288. Epub 2018 Nov 6.
- 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.
Angela Kendrick, MD principal investigator
Oregon Health and Science University
Christine Martin, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture Needle in people with Postoperative Vomiting and Nausea, run by Oregon Health and Science University 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 6 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 28 Aug 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. 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?
Yes. Results are posted in the registry (first posted 28 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Postoperative Nausea and Vomiting (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01417741, which also lists 1 linked publication.
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 28 Aug 2019.