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.

Intranasal Medications

The intranasal route is an effective means of administering sedatives and analgesics. It is a needle-free alternative to intravenous or intramuscular routes, it is not subject to first-pass metabolism, and its efficacy approaches that of intravenous administration. There is absorption through the highly vascular nasal mucosa, as well as utilization of the nose–brain pathway that bypasses systemic circulation and the blood–brain barrier and transports medications directly to the brain. Intranasal administration of sedative and analgesic medications has been shown to be safe and effective for children in a variety of settings. It provides an opportunity to avoid intravenous line placement in many situations, which may reduce the pain and anxiety associated with many diagnostic and therapeutic procedures in children. More studies are needed to compare important sedation outcomes between intranasal sedation regimens and the more common intravenous sedation regimens in order to guide best practice.