Randomized Controlled Study of Plasmaknife Tonsillectomy Versus Monopolar Tonsillectomy
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- pain
研究概览
简要总结
Study objective is to provide prospective randomized controlled data on pediatric pain levels found in PlasmaKnife tonsillectomy and monopolar tonsillectomy.
详细描述
This is a prospective, randomized controlled study to compare the efficacy of the Gyrus ACMI PlasmaKnife™ electrosurgical device used with the Gyrus ACMI Workstation versus monopolar electrosurgical device (i.e. Bovie®) for tonsillectomy.
The primary outcome will study the potential for reduced post-operative pain when the PlasmaKnife is used for tonsillectomy compared to a monopolar device. Secondary outcomes such as return to normal diet and activity as well as a range of complications including primary and secondary bleeding will be included in the study.
The study will involve approximately 100 patients at Children's Hospital of Michigan that meet the criteria for tonsillectomy (with or without adenoidectomy) for infected tonsils or airway obstruction.
The study will be documented through the use of Case Report Forms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 4 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient should be between the ages of 4 and 16 years old inclusive.
- •Patient should meet criteria for tonsillectomy.
- •Patient's guardian able and willing to complete patient diary and keep to the follow-up visit.
- •Guardian able to understand English (written and oral).
排除标准
- •Patient that has active medical implant(s) such as pacemaker, cochlear implant, etc.
- •Patient has abnormal blood coagulation, history of easy bruising, bleeding disorders or uses anti-coagulants.
- •Morbidly obese children (calculated BMI over 39)
- •Patient that has history of malignancy or acute peritonsillar abscess
- •Patient has Sickle Cell disease or is immunocompromised.
- •Patient is pregnant or lactating.
- •Active infection with fever greater than 101.5 degrees F.
- •History of heart disease, diabetes or hypertension (with systolic blood pressure > 160 mmHg).
- •Craniofacial anomaly.
- •Biopsy of tonsil needed to rule out neoplasm.
结局指标
主要结局
pain
次要结局
- return to normal activity
- return to normal diet
- medication dose taken