Recruiting
Phase 3

Anxiolysis

Sponsor:

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Code:

NCT05383495

Conditions

Laceration of Skin

Distress, Emotional

Eligibility Criteria

Sex: All

Age: 2 - 12

Healthy Volunteers: Not accepted

Interventions

Dexmedetomidine

Midazolam Nasal Spray

Nitrous oxide

Study Details

Brief 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).

Conditions

Laceration of Skin

Distress, Emotional

Study ID

NCT05383495

Start date

Dec 19, 2023

Status verified date

Mar, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 12

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intranasal dexmedetomidine

IN dexmedetomidine 3 mcg/kg \[100 mcg/mL (max 200 mcg or 2 mL)\]

experimental: Intranasal midazolam

IN midazolam 0.4 mg/kg \[5 mg/mL (max 10 mg or 2 mL)\]

experimental: Inhaled nitrous oxide

50% N2O in 50% oxygen by face mask or on-demand system

Interventions

Dexmedetomidine

Intranasal dexmedetomidine 3 mcg/kg \[100 mcg/mL (max 200 mcg or 2 mL)

Midazolam Nasal Spray

Intranasal midazolam 0.4 mg/kg \[5 mg/mL (max 10 mg or 2 mL)

Nitrous oxide

50% nitrous oxide in 50% oxygen by face mask

Primary outcome measure

  • Observational Scale of Behavioral Distress - Revised (OSBD-R) [ Time Frame: During preparation, suturing, and recovery (20 minutes) ]

Central Contacts and Locations

Central contacts

Locations

London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5W9

More Information

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Last update posted

Apr 30, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2025-04-30.