386 - Optimal dose of intranasal dexmedetomidine for laceration repair in children: a phase II dose-ranging study using the continual reassessment method

Poster Number: 386
Publication Number: 386.314

Sarah Meulendyks, The University of Western Ontario - Schulich School of Medicine & Dentistry, Kilworth, ON, Canada; Holly Stevens, London Health Sciences Centre, London, ON, Canada; Amanda Chapman, London Health Sciences Center, London, ON, Canada; Natalie Evans, The University of Western Ontario - Schulich School of Medicine & Dentistry, London, ON, Canada; Charlotte A. Mace, The University of Western Ontario - Schulich School of Medicine & Dentistry, London, ON, Canada; Christopher D. Creene, The University of Western Ontario - Schulich School of Medicine & Dentistry, London, ON, Canada; Shaily Brahmbhatt, The University of Western Ontario - Schulich School of Medicine & Dentistry, London, ON, Canada; Naveen Poonai, The University of Western Ontario - Schulich School of Medicine & Dentistry, London, ON, Canada

Background: Lacerations are the most common paediatric injury presenting to an emergency department (ED). Suture repair can be distressing, especially for young children, who commonly resist positioning and often require restraint. No effective anxiolytic for paediatric laceration repair currently exists. Recent evidence suggests intranasal dexmedetomidine (IND) may be effective for reducing procedural anxiety in children. 

Objective: Our objective was to determine the optimal dose of IND for children undergoing laceration repair.

Design/Methods: We report the interim results of a phase II, dose-ranging study using the Bayesian continual reassessment method. Children 0-17 years with a single, isolated laceration ( < 5 cm), requiring single layer closure with sutures were administered IND in increasing doses ranging from 1-4 mcg/kg (maximum 200 mcg), using a mucosal atomizer device. The primary outcome was sedation using the Paediatric Sedation State Scale (PSSS). The PSSS was scored every 30 seconds by two independent outcome assessors using video. PSSS scores of 0 or 1, 2 or 3, and 4 or 5 indicate “over”, “adequate”, and “under” sedation, respectively. Using complete case analysis, we reported the proportion of participants that achieved “adequate” sedation for > 90% of the time from sterile preparation to tying of the last suture. Secondary outcomes included adverse events (AEs) and post procedure length of stay (ppLOS).

Results: Forty-nine of 55 planned participants have been enrolled, including 31/49 (63%) males. One participant was withdrawn prior to scoring because the laceration required operative repair. The median (IQR) age and number of sutures was 4 (2,6) and 3 (2,4), respectively. All participants received lidocaine-epinephrine-tetracaine topical anesthetic. The proportion of participants that were adequately sedated using 1, 2, 3, and 4 mcg/kg IND were 1/3 (33%), 2/9 (22%), 9/15 (60%), and 12/21 (57%), respectively. There was one AE, a self-resolving decrease in oxygen saturation to < 90%, lasting 30 seconds. The participant received 4 mcg/kg and required no resuscitative interventions. The median (IQR) ppLOS for 1, 2, 3, and 4 mcg/kg IND were 67 (60, 78), 76 (60, 100), 87 (74, 106), and 113 (76, 150) minutes, respectively. All participants complied with intranasal administration.Conclusion(s): Our interim results suggest that IND is safe, well tolerated, and 3 mcg/kg balances optimal sedation and ppLOS. Additional participants will receive 3 mcg/kg and although results are pending, future studies of IND in children should consider using this administration regimen.