Preemptive Genotyping of Children and Adolescents at Risk for Surgery and Subsequent Pain Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 576
- 试验地点
- 1
- 主要终点
- Feasibility of PreEmptive Genotyping Testing
研究概览
简要总结
The purpose of this study is to see if testing for genes related to pain and pain management before surgery affects how patients are treated for pain after surgery. The investigators want to know if this information will be used to effectively treat patients for pain after surgery if the clinical staff have a chance to review it before the surgery.
详细描述
Purpose: To determine the feasibility of preemptive (preoperative) cytochrome P450 isoenzyme (CYP2D6) testing and the variability of clinical measures (postoperative) in children whose opioid selection and dosing is influenced by preemptive CYP2D6 testing compared to children whose pain management does not include CYP2D6 preemptive testing. Results from this pilot study will inform a future study investigating the utility of preemptive pharmacogenomic testing in children at risk for requiring inpatient acute pain management with opioids.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children, 6-17 years of age and adults, 18 - 21 years with idiopathic scoliosis and/or pectus excavatum scheduled for surgical clinic visit
- •BMI < 30
- •Cognitively able to use a 0 - 10 numerical rating scale (NRS) to report level of pain
- •Parents give permission (and children give assent when appropriate) or adult participants give consent for CYP2D6 results to be placed in Cincinnati Children's Hospital Medical Center (CCHMC's) EPIC
排除标准
- •• Who had prior surgery for idiopathic scoliosis and/or pectus excavatum
- •Who have prior CYP2D6 testing or Genetic Pharmacology Service (GPS) Psychiatry Panel documented in EPIC
- •Who are taking prescription medication known to inhibit or induce CYP2D6
- •Who are taking prescription medication known to inhibit (e.g. voriconazole) or induce (e.g. carbamazepine and rifampin) CYP3A4
- •Who have liver or renal failure
- •Who have history of narcotic abuse
结局指标
主要结局
Feasibility of PreEmptive Genotyping Testing
时间窗: From initial clinic visit to post-operative discharge, expected average of three months
The Investigator will use descriptive and summary statistics to determine the feasibility of preemptive CYP2D6 testing in children evaluated during a clinic visit for potential surgery.
次要结局
- Analgesia Effectiveness(Admission for surgery, up to two weeks)
- Analgesia Toxicity(Admission for surgery, up to two weeks)