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Recruiting NCT07495826

PRedictors Of Maladaptive Behaviors in Children Undergoing Procedural SEDation

Conditions: Procedural Sedation and Analgesia

Sex: All
Ages: 1 Year – 17 Years
Healthy volunteers: No
Enrollment: 2145
Sponsor: London Health Sciences Centre Research Institute

Location: London Health Sciences Centre London Ontario

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 \

Eligibility Criteria

Inclusion Criteria: * Children and adolescents 1-17 years undergoing procedural sedation or anxiolysis with any agent for any indication in the ED and dental clinics Exclusion Criteria: * 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

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Source: ClinicalTrials.gov (NCT07495826). StuddyBuddy aggregates publicly available trial information.