Study objective: Administration of intranasal dexmedetomidine for sedation is comfortable and effective in children who are afraid of needles, and it offers efficient sedation similar to that of intravenous administration. We performed a systematic review and meta-analysis to evaluate the clinical effects of the pre-procedural administration of intranasal dexmedetomidine. Design: We identified randomized controlled trials (RCTs) that compared intranasal dexmedetomidine administration to other administration methods of various sedatives or placebo from MEDLINE, EMBASE, Cochrane, KoreaMed and hand searches of trial registries. Setting: Pediatrics who underwent interventional procedures and surgeries. Patients: Children under the age of 18. Interventions: Studies were included if they were compatible with the criteria that dexmedetomidine was administered intranasally. Measurements: We pooled data on the sedation status as the primary outcome and considered the behavioral score, blood pressure, heart rate and side effects to be secondary outcomes. Risk ratio (RR) and the standardized mean difference (SMD) with 95% confidence intervals (CIs) were calculated for dichotomous and continuous outcomes, respectively. Main results: This meta-analysis included 11 RCTs. The SMD for the sedative effects of intranasal dexmedetomidine was 2.45 (random, 95% CI; -3.33, -1.58) for continuous outcomes and RR of unsatisfactory patient outcome was 0.42 (M-H, random 95% CI; 026, 0.68 I-2 = 45%) for dichotomous outcomes compared to that of intranasal saline. The SMD for the sedative effects of intranasal dexmedetomidine was -0.41 (random, 95% CI; -1.09, 0.27 I-2 = 69%) for continuous outcomes and RR was 0.43 (M-H, random 95% CI; 0.32, 0.58 I-2 = 0%) for dichotomous outcomes compared to that of per os benzodiazepines. Conclusions: This review suggests that intranasal dexmedetomidine is associated with better sedative effects than oral benzodiazepines without producing respiratory depression, but it had a significantly delayed onset of effects. (C) 2017 Elsevier Inc. All rights reserved.