Post-surgical Pain Assessment in Children: Roles of Skin Conductance and Genomics
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- skin conductance measurements
研究概览
简要总结
Pain assessment in infants and toddlers is quite challenging since children in these populations are nonverbal or preverbal and cannot describe the presence and severity of pain that they perceive. Over the last decade, advances in the field have included the development of behavioral scoring systems for the assessment of acute pain . However, although they have been validated, these commonly used methods of pain assessment are largely subjective and rely on a highly trained observer. An objective continuous measure of pain would be an important addition to standard behavioral pain scores which require nurses to monitor the child's behavioral responses.
详细描述
After standard general anesthetic mask induction, 0.5 ml of blood will be drawn for genetic analysis when the intravenous catheter is sited. A member of the research team will manually transport an appropriately-labeled blood collection tube to the Department of Anesthesiology Perioperative Genomics Laboratory for storage and further preparation for genetic analysis. The samples will be stored until the investigators have enough to process. The results will be stored in a secure database. The surgical procedure, anesthesia technique, intraoperative analgesia treatment and initial postoperative analgesia treatment will be standardized.Upon arrival in the Post-Anesthesia Care Unit (PACU), the child will be connected to standard monitors as per standard of care. Pain scores will be recorded on a scale of 0-10 (FLACC, Face, legs,activity, cry, consolability scale) scale. A member of the research team will apply the skin conductance (SC) monitor on the child's hand or foot.This will be used to measure SC values that will be saved on a laptop computer and the SC data will be analyzed off-line.
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
- — 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children <5 years of age
- •Presenting for palatal repair (palatoplasty) or tonsillectomy/adenoidectomy
- •American Society of Anesthesiologists (ASA) physical status of 1 - 3
排除标准
- •Children > 5 years of age
- •On chronic pain treatment
- •Pre-operative use of analgesics
- •Allergies to any anesthetics or analgesia products
- •Diagnosis of Cystic fibrosis
- •American Society of Anesthesiologists (ASA) physical status > 3
结局指标
主要结局
skin conductance measurements
时间窗: 2 years
The skin conductance monitor will be attached to the patient in the Post-Anesthesia Care Unit (PACU) for 1 hour and the skin conductance values will be analyzed off-line. Corresponding pain scores on a scale of 0-10 using the FLACC (Face, Legs, Activity, Cry and Consolability) scale will be noted every 5 minutes for a period of 1 hour. The skin conductance values will be measured in microsiemens, also the frequency of the skin conductance responses per second will be measured. The ability of skin conductance monitor to predict post-operative pain scores, sensitivity and specificity will be measured.
次要结局
- Effect of single nucleotide polymorphisms in the mu-opioid receptor A118G on post-operative pain scores(2 years)
研究者
Priti G. Dalal
Professor
Milton S. Hershey Medical Center