Abstract
BACKGROUND: Intranasal Dexmedetomidine (IN-DEX) is a promising agent for pediatric procedural sedation due to its non-invasive route and favorable safety profile. However, a comprehensive synthesis quantifying its clinical timeline and safety as monotherapy is lacking. This meta-analysis assesses the efficacy and adverse events of IN-DEX as a standalone sedative in children. METHODS: Following PRISMA 2020 guidelines and PROSPERO registration (CRD420250652456), this meta-analysis systematically searched PubMed, ScienceDirect, and SciELO for intranasal dexmedetomidine monotherapy in children under 18 years from January 1, 2003, to July 1, 2025. Key outcomes included sedation success, onset, and duration. Data were pooled using a random-effects model, with risk-of-bias assessed via RoB2. We performed sensitivity and subgroup analyses and evaluated evidence certainty using the GRADE approach. RESULTS: Twenty-eight RCTs were included. The overall pooled mean onset time was 18.9 minutes and duration was 60.3 minutes, though both had very low evidence certainty due to high heterogeneity (I² > 99%). The overall success rate was 79.58%. Notably, in a subgroup of low-to-moderate risk-of-bias studies, a dose of [2, 3) mcg.kg(-1) achieved an 84.04% success rate, supported by high-quality evidence (GRADE: High, I² = 0%). The pooled proportions for key adverse events were hypotension (8.24%), bradycardia (5.08%), and desaturation (2.76%). CONCLUSION: IN-DEX is an effective monotherapy for pediatric procedural sedation. Doses of [2, 3) mcg.kg(-1) are associated with high success rates, supported by high-quality evidence. While IN-DEX demonstrates a favorable respiratory profile with low desaturation rates, its use requires vigilant hemodynamic monitoring due to the risks of hypotension and bradycardia.