Anxiolysis for Laceration Repair in Children

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lawson Health Research Institute
• Treatments: Dexmedetomidine; Midazolam; Nitrous Oxide

Criteria

Inclusion Criteria:

1. Age 1-12.99 years (maximum 65 kg)

2. Single laceration < 5 cm requiring single layer closure with simple interrupted sutures alone

3. Isolated injury

4. Managed within the emergency department

5. Predicted to resist positioning for repair by parent, child life specialist, or nurse

6. Local anesthesia planned to include only lidocaine-epinephrine-tetracaine (LET) with or without subcutaneous local anesthetic

Exclusion Criteria:

1. Injury related: laceration repair requiring procedural sedation or regional nerve block, other injuries requiring reduction (fracture or dislocation) or repair (nailbed injury or laceration), lacerations containing foreign body material

2. IN dexmedetomidine related: history of hypersensitivity, occlusion of at least one nare due to mucus, polyps, septal deviation, etc., concomitant use of an alpha2-adrenergic receptor agonist, bradycardia or hypotension for age, known renal insufficiency, uncorrected mineralocorticoid deficiency, congenital heart disease or cardiac conduction disorder

3. IN midazolam related: history of hypersensitivity

4. N20 related: history of hypersensitivity, conditions associated with impaired level of consciousness (head injury with severe mechanism, ingestion of alcohol or other psychoactive drugs, postictal state), conditions associated with potential accumulation of gas within body spaces, cardiac ischemia or chest pain, pulmonary hypertension or pulmonary edema, vitamin B12 deficiency, phenylketonuria, cobalamin disorders, immunosuppression, known pregnancy

5. Caregiver related: not the primary care provider, unable to read or understand English or French above at least a grade 8 literacy level in the absence of a native language interpreter