Acupuncture and Nausea/Vomiting in Pediatric Patients
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|ClinicalTrials.gov Identifier: NCT01417741|
Recruitment Status : Completed
First Posted : August 16, 2011
Results First Posted : August 28, 2019
Last Update Posted : August 28, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Vomiting and Nausea||Device: Acupuncture Needle||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||164 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|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?|
|Actual Study Start Date :||August 2011|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||December 31, 2018|
No Intervention: Standard Therapy Only
Patients will not receive acupuncture. Standard anti-emetic therapy will be given.
Experimental: 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.
Device: Acupuncture Needle
A small 1.8 mm needle to be placed in the P6 acupuncture point on the wrist
Other Name: Seirin Pyonex
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01417741
|United States, Oregon|
|Oregon Health and Sciences University|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Angela Kendrick, MD||Oregon Health and Science University|
|Principal Investigator:||Christine Martin, MD||Oregon Health and Science University|