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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture Needle | Device | A small 1.8 mm needle to be placed in the P6 acupuncture point on the wrist |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Angela Kendrick, MD | Oregon Health and Science University | Principal Investigator |
| Christine Martin, MD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health and Sciences University | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30397904 | Background | 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. |
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randomization of three patients unrecorded, so 161 properly randomized patients were entered in study
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Therapy Only | Patients will not receive acupuncture. Standard anti-emetic therapy will be given. Standard anti -emetic therapy at our institution for children having a T and A consists of Ondansetron 0.15 mg/kg and dexamethasone 0.25mg/kg up to 10 mg. |
| FG001 | Acupuncture Plus Standard Therapy | Bilateral P6 acupuncture applied after anesthesia induction and removed at the termination of the surgery. Patients will also receive standard anti-emetic therapy. Acupuncture Needle: A small 1.8 mm needle to be placed in the P6 acupuncture point on the wrist |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Therapy Only | Patients will not receive acupuncture. Standard anti-emetic therapy will be given. Children ages 3-9 undergoing tonsillectomy with or without adenoidectomy were the population studied in both arms. |
| BG001 | Acupuncture Plus Standard Therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | 24 hours |
|
Post-operative day (POD) 0 and day 1
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Therapy Only ( AE Group) | Patients will not receive acupuncture. Standard anti-emetic therapy will be given. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christine Martin, assistant professor | OHSU department of APOM | 503 494 7641 | martich@ohsu.edu |
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
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Bilateral P6 acupuncture applied after anesthesia induction and removed at the termination of the surgery. Patients will also receive standard anti-emetic therapy. Acupuncture Needle: A small 1.8 mm needle to be placed in the P6 acupuncture point on the wrist |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Study took place at DCH ( Children's hospital ) in Portland OR | Number | participants |
|
Bilateral P6 acupuncture applied after anesthesia induction and removed at the termination of the surgery. Patients will also receive standard anti-emetic therapy.
Acupuncture Needle: A small 1.8 mm needle to be placed in the P6 acupuncture point on the wrist
In phase 1 and 11 recovery units: 6 patients ( 7%) of 86 experienced nausea or vomiting On POD one: 31 or 43% experienced PONV
|
|
| 0 |
| 75 |
| 0 |
| 75 |
| 0 |
| 75 |
| EG001 | Acupuncture Plus Standard Therapy | Bilateral P6 acupuncture applied after anesthesia induction and removed at the termination of the surgery. Patients will also receive standard anti-emetic therapy. Acupuncture Needle: A small 1.8 mm needle to be placed in the P6 acupuncture point on the wrist | 0 | 86 | 0 | 86 | 0 | 86 |
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| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |