Intranasal Dexmedetomidine Compared to a Combination of Intranasal Dexmedetomidine with Ketamine for Sedation of Children Requiring Dental Treatment: A Randomized Clinical Trial.

Outpatient pediatric sedation is challenging. This study aimed to test intranasal dexmedetomidine efficacy as a single drug or combined with ketamine (DK) to sedate children undergoing dental treatment. Children < 7 years were randomized into dexmedetomidine 2 mcg/kg and ketamine 1 mg/kg (DK) or dexmedetomidine 2.5 mcg/kg (D) groups. Videos from the dental sedation allowed the systematic assessment of children's behavior (primary outcome) according to the Ohio State University Behavioral Rating Scale (OSUBRS). Secondary outcomes were parental and dentist satisfaction, adverse events, and recovery time. The data were analyzed descriptively and through regression models. Participants were 88 children (44 per group; 50 boys). The duration of quiet behavior (OSUBRS) was higher than 50% (DK mean 58.4 [standard deviation 38.1]; D 55.2 [39.1]; p = 0.225). Parents (DK 78.0 [32.2]; D 72.7 [35.1]; p = 0.203) and dentists (KD 62.7 [41.0]; D 62.8 [40.1]; p = 0.339) were overall satisfied. Adverse events occurred in 16 cases (DK n = 10, 62.5%; D n= 6, 37.5%; p = 0.104) and were minor. The median recovery time in the DK group was 1.3 times greater than in group D (p < 0.05). Intranasal sedation with dexmedetomidine alone is equally efficacious and satisfactory for pediatric sedation with fewer adverse events and faster recovery than the DK combination.