Assessment of 14-Day Outcomes With the Peak® Surgery System Versus the Traditional Electrocautery Method in Children Ages 3 to 18 Years Undergoing Tonsillectomy With Adenoidectomy for Sleep Disordered Breathing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 主要终点
- Pain Control Assessed by Validated Pain Scores: Days to Having no Pain Following Surgery
研究概览
简要总结
Given the large numbers of children who undergo tonsillectomy (by the time a child is 15 years old, 13% of his/her peers will have had a tonsillectomy), the significant morbidity, and direct and indirect costs associated with absences for child from school or parent from work or other responsibilities, it is vitally important to identify surgical techniques which will minimize pain and serious negative outcomes. This study aims to compare a new surgical technique, PEAK® Surgery System, with electrocautery, one of the most commonly used methods for tonsillectomy with or without adenoidectomy in children 3 to 6 years old with a diagnosis of sleep-disordered breathing.
In this project, the investigator will evaluate intra-operative outcomes including, surgery time and bleeding rates, and post-operative pain scores, bleeding rates, time to resumption of normal diet and activity, analgesic type and use, and frequency of emergent visits over 14 days following surgery.
The hypothesis is that there is no difference in outcomes between the traditional extracapsular electrocautery dissection method of tonsillectomy versus the newly introduced Peak® Surgery System.
The long-term goal is to minimize pain and risk of bleeding and shorten the time to resumption of normal eating and activities in children undergoing tonsillectomy.
详细描述
SPECIFIC AIMS:
- Specific Aim 1: To assess differences in pain control, assessed by validated pain scores and requirement for postoperative analgesia, during the 14-day post-operative period.
- Specific Aim 2: To assess differences in bleeding (hemorrhage) both intraoperatively and 24 hours post-surgery (immediate period) and between 24 hours and 14 days post-operatively (delayed period).
- Specific Aim 3: To assess differences in other outcomes (time to resumption of normal diet and activities) and adverse events (emergent visits for medical care) between 24 hours and 14 days post-operatively.
BACKGROUND AND SIGNIFICANCE:
Epidemiology of Tonsillectomy in Children. Tonsillectomy is the second most commonly performed procedure in children under 15 years old, second to myringotomy and pressure equalization tube placement. It is estimated that 583,000 outpatient tonsillectomy procedures were performed in children in the US in 2006 accounting for 16% of all ambulatory surgeries with the greatest number (103/10,000) in children ages 0 to 6 years old. In this age group, diagnosis of airway obstruction or sleep disturbance accounts for the majority of surgery indications and tonsillectomy with adenoidectomy account for 90% of the procedures performed (vs. 10% for tonsillectomy alone). Nemours Jacksonville surgeons performed 995 tonsillectomies with/without adenoidectomy at Wolfson Children's Hospital in children 3 to 6 years old with sleep-disordered breathing from 2010-2011.
In this project, the investigators will compare electrocautery surgical method with the PEAK® Plasma Surgery System [PEAK PlasmaBlade® TnA Tonsil and Adenoid Tissue Dissection Device] (Medtronic, Inc), a recently marketed device. There are no published studies comparing the PEAK® system with other traditional methods of performing adenotonsillectomy. Nemours otolaryngologists currently use the PEAK® system for adenotonsillectomies in children 3 to 18 years of age with a diagnosis of sleep-disordered breathing. The PEAK® system generates plasma, "an electrically conductive cloud produced when radiofrequency energy contacting tissue and the tissue breaks down". The system was designed to have the precision of a scalpel, minimal bleeding as with electrosurgery, but reduced collateral thermal tissue damage. Data from the Medtronic website indicates the temperature profile from the PEAK® system to be approximately half that associated electrosurgery at similar cut settings; and human studies indicate a 66% to 80% reduction in thermal injury depth.
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
- Single (Care Provider)
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are aged 3 up to 18 years old; children younger than 3 years are excluded because of a higher risk of perioperative complications such as requiring an overnight hospitalization and dehydration after discharge resulting in an emergency department visit or hospitalization
- •Clinical diagnosis of sleep disordered breathing or obstructive sleep apnea 10 or recurrent tonsillitis
- •Presence of adenotonsillar hypertrophy
排除标准
- •Diagnosis of bleeding disorders*
- •Craniofacial malformation
- •Previous adenotonsillectomy
- •Suspected lymphoma
- •Developmental delay
- •Diabetes or any other disease that slows wound healing
- •Peritonsillar abscess
- •Expressive language disorder
- •Hematologic wound healing disorder or necrotizing dermatosis,
- •Implanted electric device
- •Mucopolysaccharidosis
- •Use of nonsteroidal anti-inflammatory drugs in the two weeks prior to the surgery
- •Allergy to medication(s) used in this protocol
- •Other planned surgical procedure during this surgical period
- •Chronic pain disorder
- •Planned hospital admission
- •We will use the following set of questions to evaluate for bleeding issues. If all are answered "no", then the child will be enrolled. If any are answered "yes", the child will be excluded and the family will be referred for a Hematology consult.
- •Has your child been told he/she has a bleeding disorder?
- •Does anyone in the child's family (grandmother, grandfather, mother, father, siblings) have a known bleeding disorder?
- •Does your child have easy bruising or difficulty stopping bleeding when he/she gets a cut or scratch?
- •If your child has had had surgery before, did the surgeon indicate that controlling bleeding was difficult or was your child required to come back to the hospital for bleeding control?
研究组 & 干预措施
Surgical Instrument
PEAK® Plasma Surgery System [PEAK PlasmaBlade® TnA Tonsil and Adenoid Tissue Dissection Device] (Medtronic, Inc) is a marketed device. The PEAK® system generates plasma, "an electrically conductive cloud produced when radiofrequency energy contacting tissue and the tissue breaks down". The system was designed to have the precision of a scalpel, minimal bleeding as with electrosurgery, but reduced collateral thermal tissue damage. The PEAK® Plasma System setting will be standardized for tonsils, to 2 for coagulation and 1 for cutting; and for adenoids, to 7 for coagulation, and 7 for cutting.
干预措施: PEAK® Plasma System (Device)
Electrosurgery
Electrosurgery, also known as thermal cautery, refers to a process in which a direct or alternating current is passed through a resistant metal wire electrode, generating heat. The heated electrode is then applied to living tissue to achieve hemostasis or varying degrees of tissue destruction. It is commonly used for tonsillectomy and adenoidectomy in pediatric patients. The electrocautery setting will be standardized to 12 for tonsils and 30 for adenoids.
干预措施: Electrosurgery (Device)
结局指标
主要结局
Pain Control Assessed by Validated Pain Scores: Days to Having no Pain Following Surgery
时间窗: during the 14-day post-operative period
To assess differences in pain control, assessed by validated pain scores and requirement for postoperative analgesia, during the 14-day post-operative period in children ages 3 to 18 years undergoing adenotonsillectomy with a clinical diagnosis of sleep-disordered breathing using the traditional Extracapsular Electrocautery Dissection Method versus the Peak® Surgery System Method. Assessment of subjective pain. The child will be asked by the parent to grade severity of pain daily using the Wong-Baker FACES pain rating scale in the morning before eating, drinking, or taking analgesics. The Wong-Baker FACES pain rating scale is a 0 to 10 numerical rating scale (0, 2, 4, 6, 8, 10) with faces indicating the level of pain from a happy face at a score of 0 to a crying face at a score of 10. The scale is recommended for children 3 years and older. Type and frequency of pain medication will be recorded.
次要结局
- Number of Participants Who Experienced Bleeding Intraoperatively and 24 Hours Post-surgery (Primary Period)(intraoperatively and 24 hours post-surgery (primary period))
- Number of Participants Who Experienced Bleeding Between 24 Hours and 14 Days Post-operatively (Secondary Period)(between 24 hours and 14 days post-operatively (secondary period))
- Adverse Events (Emergent Visits for Medical Care)(from discharge to 14 days post-operatively)
- Days to Resumption of Normal Diet(from discharge to 14 days post-operatively)
- Days to Resumption of Normal Activities(from discharge to 14 days post-operatively)
研究者
Kathryn Blake, PharmD
Director, Center for Pharmacogenomics and Translational Research
Nemours Children's Clinic