PRedictors Of Maladaptive Behaviors in Children Undergoing Procedural SEDation

Condition(s) studied

Study summary

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

Eligibility

Primary outcome measure(s)

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

Trial sites (2)

More London Health Sciences Centre Research Institute trials in Canada