Chronic Postsurgical Pain in Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Change in Brief Pain Inventory (BPI) score from 1 week preoperative to 1, 3, 6, and 12 months postoperative
研究概览
简要总结
The study purpose is to document the typical trajectory of perioperative pain experience in Cerebral Palsy (CP) and to identify important predictive factors for the development of chronic postsurgical pain. The main aims of the investigators are to:
- Quantify the trajectory of pain and opioid use in the context of orthopedic surgery in children with CP.
- Identify predictors for CPSP in children with CP and develop an applicable risk index.
- Examine relationships between perioperative pain severity and functional/mobility outcomes achieved by orthopedic surgery in children with CP.
Participants will complete:
- Questionnaires/Surveys via email and text message
- In-person Sensory Tests
- In-person Gait and Motion Analysis
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CP diagnosis
- •Have a scheduled lower extremity or spine orthopedic surgery
排除标准
- •Non-English speaking and reading parent/guardian
结局指标
主要结局
Change in Brief Pain Inventory (BPI) score from 1 week preoperative to 1, 3, 6, and 12 months postoperative
时间窗: 1 month preoperative, and 1, 3, 6, and 12 months postoperative
The BPI assesses pain location, pain intensity at worst, least, average, and right now as well as the degree to which pain interferes with activities of daily living (e.g., sleep, relationships, and mobility). Items are scored on an 11-point scale (0 = does not interfere, 10 = completely interferes) creating a total interference score ranging from 0-120 (higher scores mean more pain interference). The BPI has been adapted for and tested with individuals with severe CP, resulting in excellent internal consistency (Cronbach's alpha = 0.89) and validity evidence \[1, 29, 30\]. The BPI will take parents/children 1-2 minutes to complete.
次要结局
- Gait Outcomes Assessment List (GOAL)(Any time preoperative and 12 months postoperative)
- Dalhousie Pain Interview (DPI)(1 month preoperative, and 1, 3, 6, and 12 months postoperative)
- SNAKE (Schlaffragebogen für Kinder mit Neurologischen und Anderen Komplexen Erkrankungen)Sleep Questionnaire(1 month preoperative, and 1, 3, 6, and 12 months postoperative)
- Numeric Rating Scale (NRS)(From Post-Operative Day (POD) 3-90)
研究者
Chantel Burkitt
Principal Investigator
Gillette Children's Specialty Healthcare