Risk Factors for Pediatric Emergence Agitation and Post-operative Pain Following Maxillofacial Surgery and Analysis of Serum or Urine Metabonomics in Children With Agitation-An Exploratory Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Risk factors for pain and emergence agitation following maxillofacial surgery in children
研究概览
简要总结
It is known that some factors are associated with emergence agitation(EA), and investigators are still unable to predict accurately those who undergoing maxillofacial surgery are at great risks.This study intend to identify the risk factors for EA and to explore the mechanism of EA , which is helpful for early prediction, prevention and treatment in children.
详细描述
This study was divided into two parts. The first part, multivariate regression analysis were conducted to identify the risk factors for pain and EA following maxillofacial surgery in children. The second part, metabolomics research was used to explore the relationship between metabolites and EA in children.
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
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing palatopharyngoplasty/tonsillar and/or adenoidectomy, auricle reconstruction, and photodynamic therapy for vascular malformations on face.
- •Aged between 3 years and 12 years.
- •American Society of Anesthesiologists(ASA) class I-II.
排除标准
- •Patients with developmental delays.
- •Patients with mental disorders.
- •Patients with severe liver and kidney damage,or other heart and lung disease.
- •Reject to participate in the trials.
- •Eligibility Criteria in Part II
- •Inclusion Criteria:
- •Patients who underwent adenoidectomy or adenotonsillectomy in part I of this study.
- •Aged between 3 years and 7 years.
- •American Society of Anesthesiologists(ASA) class I-II.
- •Patients who underwent sevoflurane anesthesia maintainance.
- •Exclusion Criteria:
- •Patients with developmental delays or mental disorders.
- •Patients with neurological or psychiatric diseases.
- •Patients with severe liver and kidney damage,or other heart and lung disease.
- •Patients with metabolic diseases or family inherited diseases.
- •Patients who received drug treatment or intravenous nutritional supports.
结局指标
主要结局
Risk factors for pain and emergence agitation following maxillofacial surgery in children
时间窗: within 48 hours
Children aged 3-12 years who undergoing palatopharyngoplasty/adenoidectomy or adenotonsillectomy, auricle reconstruction, and photodynamic therapy for vascular malformations were enrolled in this study. The general information of children, preoperative anxiety state, preoperative anxiety state of parents, operation type, anesthesia method, analgesic drug, postoperative pain and emergence agitation degree were collected. Multivariate regression analysis were conducted to identify the risk factors for pain and emergence agitation following maxillofacial surgery in children.
The levels of serum and urine metabolites in EA
时间窗: within 24 hours
Children who underwent adenoidectomy or adenotonsillectomy in part I of this study were included. Urine (5ml) and peripheral venous blood (1ml) samples were collected before anesthesia and immediately after completion of agitation score. EA was defined as a Pediatric anesthesia emergence delirium(PAED) score ≥12 points. Children in EA group were matched with non-EA group, and UPLC-Q TOF/MS analysis was performed to identify the metabolites between two groups during the recovery period.
次要结局
未报告次要终点
研究者
Jingjie Li
vice-director
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University