Comparison of intranasal dexmedetomidine versus oral midazolam for premedication in pediatric patients: an updated meta-analysis with trial-sequential analysis
Comparação de dexmedetomidina intranasal versus midazolam oral para pré-medicação em pacientes pediátricos: uma meta-análise atualizada com análise sequencial de ensaio
Eduardo Maia Martins Pereira, TatianaSouza do Nascimento, Mariana Gaya da Costa, Eric Slawka, Carlos Galhardo Júnior
Abstract
Background
Midazolam is routinely used as preanesthetic medication in pediatric patients. Recently, dexmedetomidine has emerged as an alternative as a premedicant. We aimed to add more evidence about the efficacy and safety of two common routes of administration for pediatric premedication: oral midazolam versus intranasal dexmedetomidine.
Methods
We systematically searched Randomized Controlled Trials (RCTs) involving patients ≤ 18 years old undergoing preanesthetic medication and comparing intranasal dexmedetomidine with oral midazolam. Risk Ratio (RR) and Mean Difference (MD) with 95% Confidence Intervals (95% CI) were computed using a random effects model. Trial-sequential analyses were performed to assess inconsistency.
Results
Sixteen RCTs (1,239 patients) were included. Mean age was 5.5 years old, and most procedures were elective. There was no difference in satisfactory induction or mask acceptance (RR = 1.15, 95% CI 0.97–1.37; p = 0.11). There was a higher incidence of satisfactory separation from parents in the dexmedetomidine group (RR = 1.40; 95% CI 1.13–1.74; p = 0.002). Dexmedetomidine was also associated with a reduction in the incidence of emergence agitation (RR=0.35; 95% CI 0.14–0.88; p = 0.02). Heart rate and mean arterial pressure were marginally lower in the dexmedetomidine group but without clinical repercussions.
Conclusion
Compared with oral midazolam, intranasal dexmedetomidine demonstrated better separation from parents and lower incidence of emergence agitation in pediatric premedication, without a difference in satisfactory induction. Intranasal dexmedetomidine may be a safe and effective alternative to oral midazolam for premedication in pediatric patients.
Keywords
Resumo
Introdução
Midazolam é usado rotineiramente como medicação pré-anestésica em pacientes pediátricos. Recentemente, a dexmedetomidina surgiu como uma alternativa como pré-medicamento. Nosso objetivo foi adicionar mais evidências sobre a eficácia e segurança de duas vias comuns de administração para pré-medicação pediátrica: midazolam oral versus dexmedetomidina intranasal.
Métodos
Pesquisamos sistematicamente ensaios clínicos randomizados (ECR) envolvendo pacientes ≤ 18 anos de idade submetidos a medicação pré-anestésica e comparando dexmedetomidina intranasal com midazolam oral. A Razão de Risco (RR) e a Diferença Média (DM) com Intervalos de Confiança de 95% (IC 95%) foram calculadas usando um modelo de efeitos aleatórios. Análises experimentais sequenciais foram realizadas para avaliar a inconsistência.
Resultados
Dezesseis ECRs (1.239 pacientes) foram incluídos. A média de idade foi de 5,5 anos e a maioria dos procedimentos foi eletiva. Não houve diferença na indução satisfatória ou aceitação da máscara (RR = 1,15, IC 95% 0,97–1,37; p = 0,11). Houve maior incidência de separação satisfatória dos pais no grupo dexmedetomidina (RR = 1,40; IC 95% 1,13–1,74; p = 0,002). A dexmedetomidina também foi associada a uma redução na incidência de agitação ao despertar (RR = 0,35; IC 95% 0,14–0,88; p = 0,02). A frequência cardíaca e a pressão arterial média foram ligeiramente mais baixas no grupo dexmedetomidina, mas sem repercussões clínicas.
Conclusão
Em comparação com o midazolam oral, a dexmedetomidina intranasal demonstrou melhor separação dos pais e menor incidência de agitação ao despertar na pré-medicação pediátrica, sem diferença na indução satisfatória. A dexmedetomidina intranasal pode ser uma alternativa segura e eficaz ao midazolam oral para pré-medicação em pacientes pediátricos.
Palavras-chave
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Submitted date:
01/24/2024
Accepted date:
05/07/2024
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