Acupuncture and Nausea/Vomiting in Pediatric Patients
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|ClinicalTrials.gov Identifier: NCT01417741|
Recruitment Status : Unknown
Verified April 2014 by Angela Kendrick, Oregon Health and Science University.
Recruitment status was: Recruiting
First Posted : August 16, 2011
Last Update Posted : April 10, 2014
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)|
|Estimated Enrollment :||200 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?|
|Study Start Date :||August 2011|
|Estimated Primary Completion Date :||August 2014|
|Estimated Study Completion Date :||August 2014|
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 ]
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
|Contact: Angela Kendrick, MD||503-494-4919||Kendrick@ohsu.edu|
|United States, Oregon|
|Oregon Health and Sciences University||Recruiting|
|Portland, Oregon, United States, 97239|
|Contact: Angela Kendrick, MD 503-494-4919 email@example.com|
|Principal Investigator: Angela Kendrick, MD|
|Principal Investigator:||Angela Kendrick, MD||Oregon Health and Science University|