Acupuncture and Nausea/Vomiting in Pediatric Patients
Recruitment status was: Recruiting
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:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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?|
- Postoperative Nausea and Vomiting [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||August 2014|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01417741
|United States, Oregon|
|Oregon Health and Sciences University|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Angela Kendrick, MD||Oregon Health and Science University|