Anesthetic Optimization in Pediatric LeFort Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Postoperative pain
研究概览
简要总结
This study will propose and evaluate a standardized LeFort osteotomy anesthetic protocol for pediatric patients at Johns Hopkins Hospital. There are two cohorts to this study: a prospective cohort who will receive the study anesthesia protocol and a historical cohort that received standard of care. The investigators hope this will help to minimize unnecessary postoperative pain management, inpatient stay, and long-term morbidity and mortality in these patients.
详细描述
This study will propose and evaluate a standardized LeFort osteotomy anesthetic protocol for pediatric patients at Johns Hopkins Hospital. There are two cohorts to this study: a prospective cohort who will receive the study anesthesia protocol and a historical cohort that received standard of care. The investigators hypothesize that implementation of this standardized protocol will show improved surgical outcomes among these patients as compared to current (discretionary) treatment. This study aims to optimize the anesthetic management of these patients in order to minimize postoperative pain management, inpatient stay, and long-term morbidity and mortality in these complex patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Undergoing Le Fort osteotomy at Johns Hopkins Hospital
- •Age >= 14 years
排除标准
- •Contraindications to standardized anesthetic protocol (intervention arm)
研究组 & 干预措施
Standardized Protocol
Preop considerations
1. Ensure CBC, PT, PTT, type and cross are available, if not obtain with preop IV access
Premed
- Acetaminophen PO 15mg/kg
- Scopolamine patch as indicated
- Midazolam as indicated PO or IV
Induction
- Standard induction with lidocaine (1.5 mg/kg), propofol (1-3 mg/kg), and rocuronium (0.6mg/kg)
- Fentanyl 100 mcg bolus
- Dexmedetomidine 0.3 mcg/kg bolus
- Nasotracheal intubation (NTI) - surgical team will suture to nasal septum
- Place an additional PIV, ideally large gauge for volume resuscitation (18g or 16g)
- Dexamethasone 4-8mg q4-6 hours per surgical request
- Tranexamic acid 30mg/kg bolus (over 15 minutes)
- Ancef 30 mg/kg bolus
Monitors /Access
- Standard ASA monitors
- Avoid placing nasal or oral temperature probe as this interferes with surgical exposure
- PIV x 2 is sufficient, have at least one large gauge PIV for volume resuscitation
- Arterial catheter not necessary but place as needed, especially if patient is medically compl
干预措施: Standardized Anesthetic Course from Premedication to Induction (Other)
结局指标
主要结局
Postoperative pain
时间窗: From hospital admission (on day of surgery) to discharge, which is expected to last 2-7 days though may be up to 30 days
The degree (as ranked on a scale from 1-10) and duration of postoperative pain, including necessity of postoperative analgesia
次要结局
- Length of stay(From hospital admission (on day of surgery) to discharge, which is expected to last 2-7 days though may be up to 30 days)
- Critical care utilization(From hospital admission (on day of surgery) to discharge, which is expected to last 2-7 days though may be up to 30 days)