Actively Recruiting
Anxiolysis for Laceration Repair in Children
Led by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Updated on 2025-04-30
300
Participants Needed
1
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a 3-arm adaptive clinical trial to the optimal light sedative for reducing distress during laceration repair in children. The investigators will compare intranasal (IN) dexmedetomidine, IN midazolam, and nitrous oxide (N20). The primary outcome is the Observational Scale of Behavioral Distress - Revised (OSBD-R).
CONDITIONS
Official Title
Anxiolysis for Laceration Repair in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 2 to 12.99 years
- Single or grouped lacerations separated by no more than 2 cm that do not require IV sedation
- Laceration repair involving sutures performed by an emergency physician or trainee
- Child or caregiver requests anxiolysis for the laceration repair
- Planned use of local anesthesia such as topical anesthetic (LET), infiltrated lidocaine, or nerve block
You will not qualify if you...
- Use of sedative, anxiolytic, or alpha-2-adrenergic receptor agonist within 24 hours before the intervention
- Allergy or hypersensitivity to any study medication
- Blockage of more than one nostril that prevents drug absorption
- Abnormal heart rate or blood pressure below 2 standard deviations of age norms
- Certain medical conditions including renal insufficiency, pulmonary hypertension, cyanotic heart disease, cardiac conduction disorders, pulmonary edema, vitamin B12 or folate disorders, phenylketonuria, or psychosis
- Impaired consciousness or unstable breathing
- Conditions that contraindicate nitrous oxide use due to gas accumulation
- Suspected or confirmed pregnancy
- Inability to verbally express pain due to motor deficits
- Caregiver unable to understand English or French without an interpreter
- Weight 65 kg or more
- Not classified as American Society of Anesthesiologists class I or II
- Presence of fracture or dislocation requiring orthopedic manipulation
AI-Screening
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Trial Site Locations
Total: 1 location
1
London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
Actively Recruiting
Research Team
N
Naveen Poonai, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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