Reducing distress in children during laceration repair
Anxiolysis for Laceration Repair in Children: A Multicenter Adaptive Randomized Trial
This study is testing which of three medications can help reduce anxiety and distress in children aged 2 to 12 during stitches for cuts.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 2 Years to 12 Years |
| Sex | All |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's Academic / other |
| Locations | 1 site (London, Ontario) |
| Trial ID | NCT05383495 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of three different anxiolytic agents—intranasal dexmedetomidine, intranasal midazolam, and nitrous oxide—in reducing emotional distress during laceration repair in children aged 2 to 12.99 years. The study is designed as a 3-arm adaptive trial, focusing on the primary outcome of behavioral distress as measured by the Observational Scale of Behavioral Distress - Revised (OSBD-R). Given the high incidence of laceration repairs in pediatric emergency departments, this research aims to identify the most effective pharmacologic approach to minimize discomfort and anxiety in young patients. The trial incorporates family preferences regarding anxiolysis, ensuring a patient-centered approach to care.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 2 to 12.99 years who require laceration repair and for whom the treating physician believes that IV sedation is not necessary.
Not a fit: Patients who have received sedatives or anxiolytics within the past 24 hours or those with hypersensitivity to any of the interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved methods for managing anxiety in children during medical procedures, enhancing their overall experience and reducing long-term psychological impacts.
How similar studies have performed: While there is existing evidence for the use of anxiolytics in pediatric care, this specific comparison of intranasal dexmedetomidine against other agents in the context of laceration repair is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: i) Age 2-12.99 years \[highest incidence of laceration repair\] ii) Single or grouped lacerations separated by no more than 2 cm for which the treating physician believes repair does not require IV sedation iii) Repair to involve sutures and performed by ED physician or designate (trainee) iv) Child or caregiver desires anxiolysis for laceration repair \[justification: incorporates family preferences based on their prior experiences or beliefs about child's response\] vii) Local anesthesia planned to involve topical anesthetic (LET), infiltrated lidocaine, ring, or thenar block Exclusion Criteria: i) Sedative, anxiolytic, or alpha-2-adrenergic receptor agonist \< 24 hours prior to interventions (may compound sedative effect and increase the SAE risk). 24-hours encompasses the duration of sedation of most agents. ii) Hypersensitivity to any intervention iii) Occlusion of \> 1 nostril due to polyps, septal deviation, or foreign body (may prevent drug absorption) iv) Hemodynamic abnormalities: bradycardia or hypotension \< 2 SD of age-related normal value v) IND contraindications: Pre-existing renal insufficiency, uncorrected mineralocorticoid deficiency, pulmonary hypertension, uncorrected cyanotic heart disease, cardiac conduction disorder, pulmonary hypertension, pulmonary edema, vitamin B12 or folate disorder, phenylketonuria, or psychosis vi) Sedation contraindications: Impaired level of consciousness or respiratory instability vii) N2O contraindications: Conditions associated with potential accumulation of gas within body spaces viii) Suspected or confirmed pregnancy (as reported by patient) ix) Inability to vocalize pain due to motor deficits (unable to apply the OSBD-R) x) Caregiver unable to complete study tasks due to insufficient comprehension of either English or French in the absence of a native language interpreter xi) Weight \>= 65 kg (to avoid under-dosing of INM or IND) x) Not American Society of Anesthesiologists class I (healthy) or II (controlled mild to moderate disease) xii) No concomitant fracture or dislocation requiring orthopedic manipulation
Where this trial is running
London, Ontario
- London Health Sciences Centre — London, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Naveen Poonai, MD
- Email: naveen.poonai@lhsc.on.ca
- Phone: 5196858500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.