Anxiolysis for Laceration Repair in Children (NCT05383495) | Clinical Trial Compass
RecruitingPhase 3
Anxiolysis for Laceration Repair in Children
Canada300 participantsStarted 2023-12-19
Plain-language summary
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).
Who can participate
Age range2 Years – 12 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 contraindicat…
What they're measuring
1
Observational Scale of Behavioral Distress - Revised (OSBD-R)
Timeframe: During preparation, suturing, and recovery (20 minutes)
Trial details
NCT IDNCT05383495
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's