The Effect of Pediatric Patient Temperament on Postoperative Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 344
- 试验地点
- 1
- 主要终点
- Temperament
研究概览
简要总结
The goal of this study is to determine if preoperative temperament is associated with postoperative pain, emergence agitation, emotional and behavioral changes, and overall parent satisfaction. This is a prospective observational study to assess preoperative temperament in pediatric patients undergoing tonsillectomy and adenoidectomy, gather demographic data, intraoperative data regarding surgical and anesthetic technique, and collect immediate postoperative data to assess pain, emergence agitation (EA), parental satisfaction as well as remote postoperative data to assess emotional and behavior changes. These data will be used to determine if patients with a specific temperament profile are more likely to experience increased pain, emergence agitation, emotional changes, and behavioral disturbances postoperatively.
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
- 2 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I or II
- •undergoing Tonsil and/or Adenoid Removal at Boston Children's Hospital
排除标准
- •history of prematurity
- •major chronic medical conditions
- •neurological impairment or developmental delay
- •parents/guardians who do not speak English or are unable to understand the questionnaires
结局指标
主要结局
Temperament
时间窗: preoperative period
Patient temperament based on the Children's Behavior Questionnaire. This is a 36 question temperament inventory completed by the caregiver. Items are scored on a scale from 1 to 7, where 1 is "extremely untrue" and 7 is "extremely true". Total scores are linked to temperament constructs of Surgency, Negative Affectivity, and Effortful Control.
Pain score
时间窗: immediately post operative period
Pain behavior to be recorded using numerical rating scale (NRS), FLACC scale or Wong Baker Faces scale as appropriate for age and developmental status. All of these scales are scored from 1-10 where higher scores indicate more pain.
emergence agitation
时间窗: immediately post operative period
Measured using the Pediatric Emergence Delirium Scale (PAED). Scored on a scale from 0-4 where total scores of 10 or greater at any time during Post Anesthesia Care Unit (PACU) stay are classified as experiencing agitation.
post hospital behavior changes
时间窗: up to 4 weeks after surgery
Measured using the Post Hospitalization Behavior Questionnaire. Questions are answered on a scale of 1-5, where 1 is less than before and 5 is more than before. Adverse behavioral outcomes to be defined as those patients who experienced behavioral changes at one or more standard deviations above the sample mean.
次要结局
未报告次要终点
研究者
Stephen Kelleher
Anesthesiologist
Boston Children's Hospital