Evaluation of the Efficacy and Safety of Multimodal Sedation with Dexmedetomidine and Ketamine (Ketodex) at Different Ratios: A Randomized Clinical Trial
Abstract
<title>Abstract</title> <p> Objectives: To evaluate the efficacy and safety of sedation with dexmedetomidine and ketamine (Ketodex) at 1:1, 1:2, 1:3 ratios in children with autism spectrum disorder undergoing dental procedures. <h4>Materials and Methods:</h4> A randomized, parallel-group, triple-blind clinical trial included 63 children with ASD randomly assigned to three groups (n = 21 each). Physiological parameters, sedation efficacy using the Houpt Scale, and adverse events were evaluated at a 5% significance level. <h4>Results:</h4> Sedation success differed significantly among groups (p < 0.001) and increased progressively with higher ketamine proportions, with the 1:3 ratio showing the highest clinical efficacy. Compared with 1:1, the odds of successful sedation were over tenfold higher with 1:2 and 85-fold higher with 1:3. The relative risk of sedation failure decreased by 64.7% and 94.1%, respectively, corresponding to numbers needed to treat of 1.91 and 1.31. Physiological parameters remained clinically stable, with no serious adverse events. Vomiting was more frequent with the 1:3 ratio, but all episodes were self-limited, required no intervention, and did not prevent completion of dental treatment. <h4>Conclusions:</h4> The Ketodex combination was effective and safe for sedating children with ASD undergoing dental treatment. The 1:3 ratio demonstrated the best overall clinical performance, with the highest sedation success rate and an acceptable safety profile, making it a promising option for the dental management of this population. Clinical Relevance: Ketodex at 1:2 and 1:3 ratios may provide effective intramuscular sedation for dental treatment in children with ASD while maintaining cardiorespiratory stability. <bold>Trial registration</bold> Brazilian Registry of Clinical Trials (ReBEC), RBR108hw8xt, registered on June 18, 2026. Universal Trial Number (UTN) U111113405747. </p>
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