PRedictors Of Maladaptive Behaviors in Children Undergoing Procedural SEDation

Recruiting now

Conditions studied: Procedural Sedation and Analgesia

In brief

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

Key facts

Study ID

NCT07495826

Run by

London Health Sciences Centre Research Institute

People needed

2145

Starts

2026-03-18

Expected to finish

2030-05-30

Last updated by the study team

2026-03-27

Who can join

Age: 1 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• London Health Sciences Centre — London, Ontario, Canada (enrolling)
• London Health Sciences Centre — Londo, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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