What factors predict delayed behavior problems in children after procedural sedation
Official title: Predictors of Maladaptive Behaviors in Children Undergoing Procedural Sedation
Run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · NCT07495826 · Data updated 2026-11-12
This study will test which factors make children aged 1–17 more likely to have delayed behavior problems (such as sleep trouble, anxiety, or aggression) after procedural sedation in emergency departments and dental clinics.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 1 Year to 17 Years |
| Sex | All |
| Enrollment | 2145 (estimated) |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's Academic / other |
| Locations | 2 sites (London, Ontario and 1 other locations) |
| Status | Recruiting |
| Started | March 18, 2026 |
| Main results expected | December 31, 2029 |
| Study ends | May 30, 2030 |
| Registry record updated | September 18, 2026 |
| Trial ID | NCT07495826 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children and adolescents aged 1–17 undergoing procedural sedation or anxiolysis in participating emergency departments or dental clinics whose caregivers can complete follow-up (English or French as applicable) and have a smartphone for SMS follow-up are ideal candidates.
✕Probably not a fit
Children whose caregivers lack the required language comprehension, do not have a smartphone for SMS follow-up, cannot complete planned follow-up, or who have been previously enrolled are unlikely to be eligible or to directly benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicentre observational study enrolling children aged 1–17 who receive procedural sedation or anxiolysis in emergency departments and dental clinics. Researchers will collect baseline measures including pre-sedation anxiety, pain, and temperament, and record sedative agents used. Caregivers will be contacted after the procedure (including via SMS) to track delayed maladaptive behaviors for up to two weeks and to measure post-sedation pain. The study will model which factors are associated with an increase in negative behaviors and estimate the proportion of children affected.
Why it matters
Potential benefit: If successful, this work could help clinicians identify children at higher risk for delayed behavioral problems and provide targeted support to reduce symptoms and family disruption.
How similar studies have gone: Small prior studies and literature from inhalational anesthesia have suggested links between younger age, pre-procedural anxiety, and maladaptive behaviors, but evidence is limited and this larger multicentre effort aims to confirm those findings.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
London Health Sciences Centre
London, Ontario, Canada Recruiting -
London Health Sciences Centre
London, Ontario, Canada Recruiting
Study contacts
- Principal investigator: Naveen Poonai, MD MSc — Western University
- Study coordinator: Naveen Poonai Principal Investigator
- Email: naveen.poonai@lhsc.on.ca
- Phone: 5196945309
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.