Actively Recruiting

Age: 1Year - 17Years
All Genders
NCT07495826

PRedictors Of Maladaptive Behaviors in Children Undergoing Procedural SEDation

Led by London Health Sciences Centre Research Institute · Updated on 2026-03-27

2145

Participants Needed

2

Research Sites

219 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

PRedictors Of Maladaptive Behaviors in Children Undergoing Procedural SEDation

Who Can Participate

Age: 1Year - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children and adolescents aged 1 to 17 years undergoing procedural sedation or anxiolysis with any agent for any indication in emergency departments and dental clinics
Not Eligible

You will not qualify if you...

  • Primary caregiver lacks English or French comprehension without a native language interpreter
  • Lack of a smartphone able to receive SMS text messages
  • Caregiver and/or patient unavailable for all planned follow-up dates
  • Previously enrolled in the study

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

London Health Sciences Centre

London, Ontario, Canada, N6A5W9

Actively Recruiting

2

London Health Sciences Centre

Londo, Ontario, Canada, N6A5W9

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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