Intranasal dexmedetomidine for procedural sedation in children: a systematic review and meta-analysis
Dexmedetomidina intranasal para sedação de procedimentos em crianças: uma revisão sistemática e metanálise
Kelvin Oliveira Rocha, Ellen Renata Ferreira de Araújo Santos, Mariana Madureira Pombeiro, Márcia Nayara da Silva Leite Fidelis, Fabiana Maria Kakehasi, Daniela Caldas Teixeira
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 randomeffects 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 highquality 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.
Keywords
Resumo
Introdução
A Dexmedetomidina Intranasal (IN-DEX) é um agente promissor para sedação de procedimentos pediátricos devido à sua via não invasiva e ao perfil de segurança favorável. No entanto, falta uma síntese abrangente que quantifique sua linha do tempo clínica e segurança como monoterapia. Esta metanálise avalia a eficácia e os eventos adversos da IN-DEX como sedativo isolado em crianças.
Métodos
Seguindo as diretrizes PRISMA 2020 e registro no PROSPERO (CRD420250652456), esta metanálise pesquisou sistematicamente PubMed, ScienceDirect e SciELO por estudos com dexmedetomidina intranasal como monoterapia em crianças menores de 18 anos, entre 1º de janeiro de 2003 e 1º de julho de 2025. Os principais desfechos incluíram sucesso da sedação, início e duração. Os dados foram agrupados usando um modelo de efeitos aleatórios, com risco de viés avaliado pelo RoB2. Foram realizadas análises de sensibilidade e subgrupos, além da avaliação da certeza da evidência pelo método GRADE.
Resultados
Foram incluídos 28 RCTs. O tempo médio geral de início foi de 18,9 minutos e a duração foi de 60,3 minutos, embora ambos apresentassem certeza de evidência muito baixa devido à alta heterogeneidade (I² > 99%). A taxa geral de sucesso foi de 79,58%. Notavelmente, em um subgrupo de estudos com risco de viés baixo a moderado, uma dose de [2, 3) mcg.kg⁻¹ alcançou taxa de sucesso de 84,04%, sustentada por evidência de alta qualidade (GRADE: Alta, I² = 0%). As proporções agrupadas para os principais eventos adversos foram hipotensão (8,24%), bradicardia (5,08%) e dessaturação (2,76%).
Conclusion
A IN-DEX é uma monoterapia eficaz para sedação de procedimentos pediátricos. Doses de [2, 3) mcg.kg⁻¹ estão associadas a altas taxas de sucesso e evidência de alta qualidade. Embora a IN-DEX demonstre um perfil respiratório favorável, com baixas taxas de dessaturação, seu uso requer monitorização hemodinâmica rigorosa devido aos riscos de hipotensão e bradicardia.
Palavras-chave
Referencias
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Submitted date:
01/08/2025
Accepted date:
22/11/2025
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