Recruiting

Maladaptive Behaviors

Sponsor:

London Health Sciences Centre Research Institute

Code:

NCT07495826

Conditions

Procedural Sedation and Analgesia

Eligibility Criteria

Sex: All

Age: 1 - 17

Healthy Volunteers: Not accepted

Study Details

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

Conditions

Procedural Sedation and Analgesia

Study ID

NCT07495826

Start date

Mar 18, 2026

Status verified date

Mar, 2026

Completion date

May 30, 2030

Anticipated

Primary completion date

Dec 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

2145 participants

Anticipated

Interventions and Outcome Measures

Arms

Procedural sedation or anxiolysis

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

Primary outcome measure

  • Post-Hospital Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS) [ Time Frame: 3 days ]

Central Contacts and Locations

Locations

London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A5W9

Contacts

Principal Investigator:

Naveen Poonai, MD MSc

London Health Sciences Centre

Recruiting

Londo, Ontario, Canada, N6A5W9

Contacts

More Information

Sponsor

London Health Sciences Centre Research Institute

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Keywords

  • procedural sedation
  • pediatrics
  • maladaptive behavior
  • pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute on 2026-03-27.