Anxiolysis for laceration repair in children: statistical analysis plan for an open-label multicenter adaptive trial (ALICE).
Arlene Jiang, Naveen Poonai, Vinolia Arthur-Hayward...
https://pubmed.ncbi.nlm.nih.gov/40775649Actively Recruiting
Phase 3
Age: 2Years - 12Years
All Genders
ID05383495
Anxiolysis for Laceration Repair in Children: A Multicenter Adaptive Randomized Trial
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
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to find the best light sedative to reduce distress in children undergoing laceration repair. The trial focuses on children aged 2 to 12 years, a common group for such procedures, and compares the effects of three treatments: intranasal dexmedetomidine, intranasal midazolam, and inhaled nitrous oxide. The study addresses the need to manage distress during laceration repair, which is a frequent cause of emergency visits and can lead to long-term anxiety if untreated. Participants will be randomly assigned to one of three groups receiving either intranasal dexmedetomidine at 3 mcg/kg, intranasal midazolam at 0.4 mg/kg, or inhaled nitrous oxide at 50% concentration with oxygen. Treatments are given before the laceration repair, which involves suturing by an emergency physician or trainee. The trial includes an adaptive design to evaluate the optimal sedative among these options. During the study, children will be monitored for behavioral distress using the Observational Scale of Behavioral Distress - Revised during preparation, suturing, and recovery over 20 minutes. Additional assessments include tracking adverse effects up to 72 hours after discharge, the need for extra sedation, physical restraint during the procedure, and any late negative behaviors following discharge. The study plans to run until the end of 2026, ensuring thorough safety and effectiveness evaluations.
CONDITIONS
Brief Title
Anxiolysis for Laceration Repair in Children
Who Can Participate
Age: 2Years - 12Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age between 2 and 12.99 years
- Single or grouped lacerations separated by no more than 2 cm
- Laceration repair not requiring intravenous sedation
- Repair involves suturing performed by an emergency physician or trainee
- Child or caregiver desires anxiolysis for the procedure
- Local anesthesia planned using topical anesthetic, infiltrated lidocaine, ring, or thenar block
You will not qualify if you...
- Use of sedative, anxiolytic, or alpha-2-adrenergic receptor agonist within 24 hours prior to intervention
- Known hypersensitivity to any study intervention
- Occlusion of more than one nostril due to polyps, septal deviation, or foreign body
- Abnormal heart rate or blood pressure below 2 standard deviations of age norms
- Pre-existing renal insufficiency or other contraindications including pulmonary hypertension and cardiac disorders
- Impaired consciousness or respiratory instability
- Conditions preventing nitrous oxide use due to gas accumulation risk
- Suspected or confirmed pregnancy
- Inability to vocalize pain due to motor deficits
- Caregiver unable to complete study tasks due to language comprehension
- Weight equal to or over 65 kg
- Not classified as American Society of Anesthesiologists class I or II
- Presence of fracture or dislocation requiring orthopedic manipulation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Single treatment during laceration repair
Participants receive one of three anxiolytic treatments to reduce distress during laceration repair: intranasal dexmedetomidine, intranasal midazolam nasal spray, or inhaled nitrous oxide by face mask.
1 treatment visit during repair procedure
Follow-up
Duration - Up to 72 hours post-discharge
Participants are monitored for adverse effects and late maladaptive behaviors following the intervention.
Follow-up contacts within 72 hours after discharge
Trial Site Locations
Total: 1 location
1
London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
Actively Recruiting
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Research Team
N
Naveen Poonai, MD
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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Published Research Related To This Trial
Anxiolysis for laceration repair in children: study protocol for an open-label multicenter adaptive trial (ALICE).
Naveen Poonai, Vinolia Arthur-Hayward, Samina Ali...
https://pubmed.ncbi.nlm.nih.gov/40465577