Pharmacokinetics of Intravenous Lidocaine Infusion in Children
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Safe serum levels of lidocaine infusion (<5 mcg/ml of lidocaine in blood)
研究概览
简要总结
To determine safe concentration level of lidocaine infusion in children.
详细描述
This study will address the working hypothesis that intravenous lidocaine may be administered as a bolus followed by an infusion with reliable and safe blood levels of lidocaine. Serial blood draws will be obtained to determine safety of lidocaine doses used in this study by measuring blood levels of lidocaine and its metabolites.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female children 3-15 years of age
- •ASA physical status 1-3
- •scheduled for colorectal surgery with abdominal incision
排除标准
- •ASA physical status > 3
- •postoperative intubation planned ahead of surgery
- •history of chronic use of opioid (use longer than 3 months)
- •history of hepatic, renal, or cardiac failure
- •history of significant liver disease including liver failure, acute or chronic hepatitis, hepatomegaly, portal hypertension and elevated liver enzymes
- •history of organ transplant
- •BMI > 30
- •history of cardiac arrhythmia
- •history of long QT syndrome
- •history of allergic reaction to lidocaine or similar agents
- •history of seizure disorder
- •patient without PICC or other central access with contraindication to inhalation induction
- •family history or known patient susceptibility to malignant hyperthermia
研究组 & 干预措施
Lidocaine
IV lidocaine bolus of 1.5mg/kg over 10 minutes followed by a 1mg/kg/hr IV lidocaine infusion.
干预措施: Lidocaine (Drug)
结局指标
主要结局
Safe serum levels of lidocaine infusion (<5 mcg/ml of lidocaine in blood)
时间窗: Samples will be collected until the end of the OR case and up to 24 hours after surgery
Blood samples will be obtained at predetermined times after start and finish of lidocaine infusion. Each sample is 1ml. Samples will be obtained at the baseline placement of IV, 0 - 3 minutes after bolus has completed, 9 - 15 minutes after bolus infusion, 4 minutes prior to end or at the end of the continuous infusion, 55 - 65 following the end of infusion, 2 - 7 hours after completion of continuous infusion and 20 - 24 hours after completion of infusion if clinical labs are also necessary.
次要结局
- Safe metabolite levels (monoethylglycinexylidide (MEGX) and glycinexylidide (GX) with intraoperative IV lidocaine infusions(Samples will be collected until the end of the OR case and up to 24 hours after surgery)