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?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 164
- 试验地点
- 2
- 主要终点
- Postoperative Nausea and Vomiting
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA 1 to 3 physical status
- •Undergoing Tonsillectomy and/or adenoidectomy
- •Consent obtained from Parent/Guardian
排除标准
- •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
研究组 & 干预措施
Standard Therapy Only
Patients will not receive acupuncture. Standard anti-emetic therapy will be given.
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.
干预措施: Acupuncture Needle (Device)
结局指标
主要结局
Postoperative Nausea and Vomiting
时间窗: 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
次要结局
未报告次要终点
研究者
Angela Kendrick
associate professor
Oregon Health and Science University