跳至主要内容
临床试验/NCT07495826
NCT07495826招募中不适用

Predictors of Maladaptive Behaviors in Children Undergoing Procedural Sedation

London Health Sciences Centre Research Institute1 个研究点 分布在 1 个国家目标入组 2,145 人开始时间: 2026年3月18日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
2,145
试验地点
1
主要终点
Post-Hospital Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS)

研究概览

简要总结

Procedural sedation for children outside of the operating room is a common practice in emergency departments, outpatient clinics, radiology suites, and dental offices for painful and anxiety-provoking procedures. However, there is emerging evidence that so-called "delayed maladaptive behaviors" (disordered sleep, anxiety, and aggression) affect nearly a quarter of children for up to 2 weeks following sedation. This can lead to poor school attendance, reduced extracurricular involvement, disruptions to caregivers' employment obligations, and poor patient satisfaction. As this phenomenon has only recently been identified, very little is known about what factors predispose children to delayed maladaptive behaviors, however, small studies suggest younger age and pre-procedural anxiety may be involved. The aim of our study is to characterize risk factors for delayed maladaptive behavior in a large multicentre study involving emergency departments, dental offices, and hospital sedation services. Understanding these risk factors may help healthcare workers prevent delayed maladaptive behaviors and provide patients with anticipatory guidance, akin to post-operative recovery instructions.

There is emerging evidence that maladaptive behaviors, including significant negative behavioral changes, can occur in children following procedural sedation. These include disordered sleep, anxiety, and aggression)1,2 and affect up to 24% of children following inhalational anesthetics3 and intravenous sedatives such as ketamine.1 Moreover, these appear to be more pronounced in children <4 years4 and can persist for up to 2 weeks post-sedation. Unfortunately, only two trials have reported delayed maladaptive behaviors.1,2 Data on immediate and delayed AEs are urgently needed for safe clinical decision-making and anticipatory guidance surrounding ED anxiolytics. In a prospective cohort study of children undergoing emergency department procedural sedation with intravenous ketamine, 22% exhibited significant negative behavioral changes 1-2 weeks after discharge, as measured by the Post-Hospitalization Behavior Questionnaire. High pre-procedure anxiety have been identified as independent predictors of these maladaptive behaviors.5 Additionally, irritability, hyperactivity, and hallucinations during recovery have been reported and are associated with lower parental satisfaction.6

详细描述

RESEARCH QUESTION What are the risk factors for delayed maladaptive behaviors in children and adolescents 1-17 years undergoing procedural sedation or anxiolysis?

OBJECTIVES i) Characterize the risk factors associated with delayed maladaptive behaviors in children undergoing procedural sedation or anxiolysis in the ED and dental clinics.

ii) Determine the proportion of children with delayed maladaptive behaviors following procedural sedation or anxiolysis.

iii) Determine the degree to which delayed maladaptive behaviors are associated with post-sedation pain.

HYPOTHESES i) An increased risk of delayed maladaptive behaviors (> 3 in negative behaviors score from pre-sedation to 3-days post-sedation) will be associated with younger age, greater pre-sedation anxiety (Modified Yale Pre-Operative Anxiety Scale score > 40), greater pre-sedation pain (Parent's Post-Operative Pain Measure - Short Form), sedative drug combinations, and baseline temperament (Integrative Childhood Temperament Screener - age < 8 years) and Integrative Late Childhood Temperament Inventory - age > 8 years). This hypothesis is based on previous associations identified in children receiving inhalational anesthetics.7-9 ii) The proportion of children with delayed maladaptive behaviors will be > 20% based on prior literature.5,10 iii) Delayed maladaptive behaviors will be associated with greater post-sedation pain.

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
1 Year 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children and adolescents 1-17 years undergoing procedural sedation or anxiolysis with any agent for any indication in the ED and dental clinics

排除标准

  • Patients where the primary caregiver lacks English or French (if applicable to site) comprehension in the absence of a native language interpreter
  • Lack a smartphone able to receive SMS text messages
  • Caregiver and/or patient are not available for all of the planned follow-up dates
  • Previously enrolled in the study

研究组 & 干预措施

Procedural sedation or anxiolysis

Children and adolescents 1-17 years undergoing procedural sedation or anxiolysis with any agent for any indication in the ED and dental clinics.

结局指标

主要结局

Post-Hospital Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS)

时间窗: 3 days

The PHBQ-AS is a caregiver-reported 11-item measure of post-hospitalization behavioral changes. The PHBQ-AS is a revision of the original PHBQ with 11 items, no subscales, and a different scoring approach that treats behavioral change as a continuous overall construct, based on average item scores, rather than relying on a count of "severe" behaviors or a threshold meant to imply clinical severity. To score the PHBQ-AS, items are averaged by summing the items for each respondent and dividing by the total number of items. The total PHBQ-AS score produces a continuous variable with higher values above 3 (the midpoint) indicating greater maladaptive behavioral changes, lower values below 3 indicating improvements in behavioral change, and values equal to 3 indicating no behavioral change. A cut-off score of 3.2 on the PHBQ-AS for the diagnosis of negative behavior has been published.33 The original PHBQ was designed to measure behavior changes after surgery or hospitalization, and has be

次要结局

  • PHBQ(Days 1, 7, 10, and 14)

研究者

发起方
London Health Sciences Centre Research Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Naveen Poonai

Principal Investigator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

研究点 (1)

Loading locations...

相似试验