Anxiolysis for Laceration Repair in Children

Launched by LONDON HEALTH SCIENCES CENTRE RESEARCH INSTITUTE OR LAWSON RESEARCH INSTITUTE OF ST. JOSEPH'S · May 16, 2022

Keywords

ClinConnect Summary

This clinical trial, titled "Anxiolysis for Laceration Repair in Children," is studying the best way to help children feel less anxious and distressed during the repair of skin cuts, known as lacerations. Researchers want to compare three different methods: a nasal spray called dexmedetomidine, another nasal spray called midazolam, and a gas called nitrous oxide. The main goal is to see which method is most effective at reducing behavioral distress in children while they receive treatment.

To be eligible for the trial, children must be between the ages of 2 and 12 and have a single laceration that needs stitches but doesn't require more intense sedation. The child or their caregiver should also want some form of calming medicine to help ease the experience. Participants can expect to receive one of the three treatments during their visit to the emergency department, and their behavior will be observed to see how well they handle the procedure. It's important to note that there are specific health conditions and recent medications that may prevent some children from participating, as the safety of the children is a top priority.

Gender

ALL

Eligibility 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