A double-blind randomized controlled trial comparing intranasal dexmedetomidine with and without fentanyl for pediatric premedication

Intranasal dexmedetomidine is effective for pediatric premedication but has a relatively slow onset. We investigated whether adding intranasal fentanyl accelerates sedation in children undergoing elective surgery. In this randomized, double-blind controlled trial, 60 children aged 1–5 years were assigned 1:1 to intranasal dexmedetomidine 1 μg/kg alone or dexmedetomidine 1 μg/kg plus fentanyl 1 μg/kg. The primary outcome was time to adequate sedation, defined as a sedation score of at least 3, assessed every 5 min until operating-room entry. Adequate sedation was observed in 28/30 and 30/30 children, respectively. Median time to sedation was 23.0 and 23.5 min (hazard ratio 0.91, 95% CI 0.54 to 1.53; p = 0.74). Complete-case mean onset times were 22.0 and 23.5 min, respectively (mean difference 1.5 min, 95% CI -3.7 to 6.6; p = 0.57). Sedation at mask introduction, mask acceptance, parental separation and parental satisfaction were similar between groups. No child developed oxygen desaturation below 95% or bradycardia requiring intervention. Adding fentanyl did not accelerate sedation or improve preoperative cooperation, providing no support for its routine addition solely to shorten sedation onset. Trial registration: Thai Clinical Trials Registry, TCTR20250812007, 12 August 2025.