IRB-HSR# 14145 R,S Methadone: Analgesia and Pharmacokinetics in Adolescents Undergoing Scoliosis Correction
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- methadone levels
研究概览
简要总结
This is a pilot study to determine the pharmacokinetics of (R,S) methadone in adolescents. A total of approximately 15 patients will be required. The purpose is to determine the levels of R, S methadone at various time intervals after drug administration. Patients will receive methadone 0.25 mg/kg IV at induction and a standardized anesthetic of remifentanil and propofol. At the conclusion of surgery (45 minutes prior to the completion), the patients will receive a loading dose of morphine based on respiratory rate. A morphine PCA will be utilized for postoperative analgesia. Pharmacokinetic data will be collected in addition to VAS scores, patient and parental satisfaction with analgesia, and a functional pain assessment.
详细描述
Study Procedures Following Surgery:
- VAS scores will be recorded at intervals of 1,2,3,4,5,6,8,12,16,20,24, 36, 48 , 72 hrs (after extubation).
- Blood samples for PK will require 5ml per sample and may be obtained from an existing IV or direct phlebotomy and will be obtained at 0min, 5min, 10 min, 15min, 20 min, 40 min, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10 hrs, 12hrs, 24hrs, 48 hrs, 72hrs, and 96hrs after study drug administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric scoliosis surgery secondary idiopathic scoliosis, congenital scoliosis,
- •Age 12 - 19 inclusive
- •ASA class I-II.
排除标准
- •Preoperative opioid therapy in previous 2 weeks
- •Known hepatic or renal impairment
- •Inability to assess pain score due to neurological impairment, hearing impairment
- •Allergy to methadone, morphine, fentanyl, propofol or remifentanil
- •Pregnant or nursing
- •Taking SSRI's, MAOI,anticonvulsants, gabapentin or lyrica
- •ASA III or greater patients are excluded
- •pre-existing chronic pain
研究组 & 干预措施
Methadone
0.25mg/kg IV of racemic methadone at the induction of anesthesia.
干预措施: methadone (Drug)
结局指标
主要结局
methadone levels
时间窗: 0min, 5min, 10 min, 15min, 20 min, 40 min, 1, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10 hrs, 12hrs, 24hrs, 48 hrs, 72hrs, and 96hrs.
Tmax (time to maximum methadone concentration) Cmax (maximum concentration) T1/2 (half-life) AUC last (area under the curve from time 0 to last sample point) AUC inf (area under the curve from time 0 to infinity) VZ (Volume of distribution in the terminal phase) CL (clearance)
次要结局
未报告次要终点
研究者
Christopher Stemland, MD
Attending Anesthesiologist
University of Virginia