Intranasal dexmedetomidine versus midazolam for procedural sedation in children: a systematic review and metaanalysis of randomized controlled trials
Background: Procedural sedation in children remains a complex clinical challenge. Midazolam has served as the conventional standard, yet intranasal dexmedetomidine has emerged as an attractive alternative offering potential advantages regarding respiratory safety alongside improved behavioral recovery. Objectives: To systematically review and meta-analyze the evidence from randomized controlled trials comparing the efficacy and safety of intranasal dexmedetomidine versus midazolam for procedural sedation in children aged 0-18 years. Methods: Adhering strictly to PRISMA guidelines, a systematic search of major databases identified relevant randomized controlled trials comparing these agents. Two independent reviewers selected eligible studies, extracted data, and conducted formal risk of bias assessments. Meta-analytic data pooling utilized random-effects models. Results: Eight trials encompassing 716 children were included. Primary endpoints proved not statistically significant: sedation onset trended faster towards midazolam (SMD=1.22; I²=96.7%), whereas satisfactory sedation trended favorably toward dexmedetomidine (RR=1.23; I²=78.4%). Importantly, dexmedetomidine significantly reduced postoperative anxiety (MD=-0.81; I²=0%), emergence delirium (RR=0.31; I²=0%), and emergence agitation (RR=0.36; I²=0%) without prolonging awakening time (MD=0.30; I²=0%). Narrative synthesis indicated fewer respiratory adverse events with dexmedetomidine. Conclusion: Primary efficacy outcomes demonstrated statistically insignificant differences, although robust evidence indicates intranasal dexmedetomidine is highly superior for pediatric behavioral recovery. Dexmedetomidine effectively minimizes emergence delirium, agitation, and anxiety without inappropriately prolonging baseline awakening times, while demonstrating a safer perioperative respiratory profile. Midazolam maintains a practical edge strictly for rapid onset. Current evidence remains heavily limited by small sample sizes and substantial clinical heterogeneity. Well-powered multicenter trials utilizing standardized outcomes are urgently needed to fully resolve clinical dosing protocols today.