Reducing distress in children during laceration repair

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of three different anxiolytic agents—intranasal dexmedetomidine, intranasal midazolam, and nitrous oxide—in reducing emotional distress during laceration repair in children aged 2 to 12.99 years. The study is designed as a 3-arm adaptive trial, focusing on the primary outcome of behavioral distress as measured by the Observational Scale of Behavioral Distress - Revised (OSBD-R). Given the high incidence of laceration repairs in pediatric emergency departments, this research aims to identify the most effective pharmacologic approach to minimize discomfort and anxiety in young patients. The trial incorporates family preferences regarding anxiolysis, ensuring a patient-centered approach to care.

Why it matters

Who can join: the full rules

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

Where it's running

• London Health Sciences Centre
  London, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Naveen Poonai, MD
• Email: naveen.poonai@lhsc.on.ca
• Phone: 5196858500

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.