Anxiolysis for Laceration Repair in Children
Recruiting now · Phase 3
Conditions studied: Laceration of Skin, Distress, Emotional
In brief
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).
Key facts
- Study ID
- NCT05383495
- Run by
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- People needed
- 300
- Starts
- 2023-12-19
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2025-04-30
Who can join
Age: 2 and older, up to 12. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- London Health Sciences Centre — London, Ontario, Canada (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.