Efeitos do midazolam oral ou da associação da s(+) ketamina oral ao midazolam oral como medicação pré-anestésica em crianças e adultos com transtorno do espectro autista submetidos à anestesia geral para assistência odontológica: ensaio clínico duplo-cego randomizado.
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Data
2021-08-27
Autores
Penna, Heber de Moraes
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Universidade Estadual Paulista (Unesp)
Resumo
Assistência odontológica convencional é frequentemente impossível em autistas. Comportamentos não colaborativos; por certas vezes, até com presença de auto e heteroagressividade, corroboram para necessidade de medicações pré-anestésicas, cujo emprego contribui para não memorização de eventos negativos. Dados científicos são escassos a respeito da condução perioperatória em autistas; destarte, o objetivo primário desta pesquisa constituiu da comparação do grau de sedação entre dois grupos paralelos, duplamente encobertos, randomizados aleatoriamente para receber midazolam oral (0,5 mg.kg-1), máximo de 15 mg; ou midazolam oral (0,5 mg.kg-1) associado à s(+) ketamina oral (3 mg.kg-1), máximo de 300 mg. Sessenta e quatro pacientes autistas, em igual proporção para cada grupo, idade entre dois e 59 anos, submetidos à anestesia geral para assistência odontológica, compuseram a amostra. A análise dicotômica do grau de sedação Ramsay 1 e 2 versus Ramsay ≥ 3 demonstrou que a associação de s(+)ketamina e midazolam favoreceu o grau de sedação com aumento da probabilidade de Ramsay ≥ 3 (Risco Relativo = 3,2 / Intervalo de Confiança 95% = 1,32 a 7,76) quando comparado ao midazolam isolado. A associação facilitou ainda obtenção do acesso venoso com maior chance de execução sem necessidade de estabilização física do paciente (Risco Relativo = 2,05 / Intervalo de Confiança 95% = 1,14 a 3,68). Não houve diferenças entre os grupos quanto ao tempo do despertar e ocorrência de eventos adversos. Concluiu-se que a associação oral de s(+) ketamina ao midazolam proporciona índices de sedação pré-anestésicos mais satisfatórios do que com midazolam puro em autistas.
Conventional dental care is often impossible in patients with autism spectrum disorder. Non-collaborative behaviors, sometimes even with self and heterous aggressiveness, corroborate to require premedications, which contribute to the non-memorization of negative events. Since scientific data is scarce regarding perioperative period in autism, therefore the primary objective of this study was to compare the degree of sedation between two parallel, double-blind groups, randomized to receive oral midazolam (0.5 mg.kg-1, maximum 15 mg) or oral midazolam (0.5 mg.kg-1) associated with oral S(+)-ketamine (3 mg.kg-1, maximum 300 mg). The sample included 64 persons with autism, aged two to 59 years who were undergoing general anaesthesia for dental care, being allocated in equal proportions to each group. According to a dichotomous analysis of sedation level (Ramsay score 1 and 2 versus Ramsay ≥ 3), oral association of S(+)-ketamine and midazolam improved sedation, with increased probability of Ramsay ≥ 3, Relative Risk = 3.2 ( 95%CI = 1.32 to 7.76) compared to midazolam alone. Combined treatment also made it easier to obtain venous access, with a higher chance of not requiring physical stabilization, Relative Risk = 2.05 (95%CI = 1.14 to 3.68). There were no differences between groups regarding time to awakening and the occurrence of adverse events. We conclude that an association of oral S(+)-ketamine with midazolam provides more satisfactory preanaesthetic sedation rates than midazolam alone in patients with austism.
Conventional dental care is often impossible in patients with autism spectrum disorder. Non-collaborative behaviors, sometimes even with self and heterous aggressiveness, corroborate to require premedications, which contribute to the non-memorization of negative events. Since scientific data is scarce regarding perioperative period in autism, therefore the primary objective of this study was to compare the degree of sedation between two parallel, double-blind groups, randomized to receive oral midazolam (0.5 mg.kg-1, maximum 15 mg) or oral midazolam (0.5 mg.kg-1) associated with oral S(+)-ketamine (3 mg.kg-1, maximum 300 mg). The sample included 64 persons with autism, aged two to 59 years who were undergoing general anaesthesia for dental care, being allocated in equal proportions to each group. According to a dichotomous analysis of sedation level (Ramsay score 1 and 2 versus Ramsay ≥ 3), oral association of S(+)-ketamine and midazolam improved sedation, with increased probability of Ramsay ≥ 3, Relative Risk = 3.2 ( 95%CI = 1.32 to 7.76) compared to midazolam alone. Combined treatment also made it easier to obtain venous access, with a higher chance of not requiring physical stabilization, Relative Risk = 2.05 (95%CI = 1.14 to 3.68). There were no differences between groups regarding time to awakening and the occurrence of adverse events. We conclude that an association of oral S(+)-ketamine with midazolam provides more satisfactory preanaesthetic sedation rates than midazolam alone in patients with austism.
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Palavras-chave
Assistência odontológica, Autismo, Ketamina, Midazolam, Transtorno do Espectro Autista, Autism, Dental care, Ketamine