Journal of Innovative Clinical Trials and Case Reports

Abstract

Methods: A systematic review and meta-analysis of randomized controlled trials was conducted in accordance with PRISMA 2020 guidelines. PubMed/MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials were searched from inception to January 2026 without language restrictions. Eligible studies included randomized controlled trials comparing oral dexmedetomidine with oral midazolam in pediatric patients. The primary outcome was satisfactory sedation at parental separation. Secondary outcomes included emergence agitation, mask acceptance, and adverse events. Risk of bias was assessed using the Cochrane Risk of Bias 2 tool. Meta-analysis was performed using a random-effects model, and results were expressed as risk ratios with 95% confidence intervals.

Results: Ten randomized controlled trials involving 842 pediatric patients were included. Oral dexmedetomidine significantly improved satisfactory sedation at parental separation compared with midazolam (RR: 1.45; P < 0.001) and was associated with a lower incidence of emergence agitation (RR: 0.42). Statistical heterogeneity was low (I² = 15%). Funnel plot analysis and Egger’s regression test demonstrated no significant publication bias (P = 0.3)

Oral dexmedetomidine appears to be a more effective premedication than oral midazolam in pediatric anesthesia, providing better sedation quality and reducing emergence agitation with a favorable safety profile.