PRedictors Of Maladaptive Behaviors in Children Undergoing Procedural SEDation

NCT07495826 | Recruiting

• 1 other identifier: 128020
• Study Type: observational
• Target: 2,145
• Locations: 1 country
• Sites: 2

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

Keywords

procedural sedation; pediatrics; maladaptive behavior; pain

Outcome Measures

Primary Outcomes (1)

• Post-Hospital Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS)

  The PHBQ-AS is a caregiver-reported 11-item measure of post-hospitalization behavioral changes. The PHBQ-AS is a revision of the original PHBQ with 11 items, no subscales, and a different scoring approach that treats behavioral change as a continuous overall construct, based on average item scores, rather than relying on a count of "severe" behaviors or a threshold meant to imply clinical severity. To score the PHBQ-AS, items are averaged by summing the items for each respondent and dividing by the total number of items. The total PHBQ-AS score produces a continuous variable with higher values above 3 (the midpoint) indicating greater maladaptive behavioral changes, lower values below 3 indicating improvements in behavioral change, and values equal to 3 indicating no behavioral change. A cut-off score of 3.2 on the PHBQ-AS for the diagnosis of negative behavior has been published.33 The original PHBQ was designed to measure behavior changes after surgery or hospitalization, and has be

  3 days

Secondary Outcomes (1)

• PHBQ

  Days 1, 7, 10, and 14

Study Arms (1)

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.

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute: lead

Study Sites (2)

London Health Sciences Centre

London, Ontario, N6A5W9, Canada

RECRUITING

London Health Sciences Centre

Londo, Ontario, N6A5W9, Canada

RECRUITING

MeSH Terms

Conditions

Agnosia; Pain

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Naveen Poonai, MD MSc

  Western University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: March 27, 2026
• Study Start: March 18, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): May 30, 2030
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)