NCT07495826 PRedictors Of Maladaptive Behaviors in Children Undergoing Procedural SEDation
| NCT ID | NCT07495826 |
| Status | Recruiting |
| Phase | — |
| Sponsor | London Health Sciences Centre Research Institute |
| Condition | Procedural Sedation and Analgesia |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,145 participants |
| Start Date | 2026-03-18 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,145 participants in total. It began in 2026-03-18 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Naveen Poonai, MD MSc
PRINCIPAL INVESTIGATOR
Western University
Frequently Asked Questions
Who can join the NCT07495826 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 17 Years, studying Procedural Sedation and Analgesia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07495826 currently recruiting?
Yes, NCT07495826 is actively recruiting participants. Visit ClinicalTrials.gov or contact London Health Sciences Centre Research Institute to inquire about joining.
Where is the NCT07495826 trial being conducted?
This trial is being conducted at London, Canada, Londo, Canada.
Who is sponsoring the NCT07495826 clinical trial?
NCT07495826 is sponsored by London Health Sciences Centre Research Institute. The principal investigator is Naveen Poonai, MD MSc at Western University. The trial plans to enroll 2,145 participants.