Comparison of Oral and Intranasal Midazolam/Ketamine Sedation in 3‒6-year-old Uncooperative Dental Patients

Abstract

Background and aims. There are several known sedative drugs, with midazolam and ketamine being the most commonly used drugs in children. The aim of this study was to compare the effect of intranasal and oral midazolam plus ketamine in children with high levels of dental anxiety.Materials and methods.A crossover double-blind clinical trial was conducted on 23 uncooperative children aged 3-6 (negative or definitely negative by Frankel scale), who required at least two similar dental treatment visits. Cases were randomly given ketamine (10 mg/kg) and midazolam (0.5 mg/kg) through oral or intranasal routes in each visit. The sedative efficacy of the agents was assessed by an overall success rate judged by two independent pediatric dentists based on Houpt’s scale for sedation. Data analysis was carried out using Wilcoxon test and paired t-test.Results. Intranasal administration was more effective in reduction of crying and movement during dental procedures compared to oral sedation (P<0.05). Overall behavior control was scored higher in nasal compared to oral routes at the time of LA injection and after 15 minutes (P<0.05). The difference was found to be statistically significant at the start and during treatment. However, the difference was no longer significant after 30 minutes, with the vital signs remaining within physiological limits. Recovery time was longer in the intranasal group (P<0.001) with a more sleepy face (P=0.004).Conclusion.. Intranasal midazolam/ketamine combination was more satisfactory and effective than the oral route when sedating uncooperative children.

187 Intranasal Ketamine for Procedural Sedation and Analgesia in Children: A Systematic Review

“…Seven studies (264 participants) were included (Fig 1 and S2 Text) [14,[21][22][23][24][25][26]. Excessive heterogeneity in outcome measures, study design, comparators, dosing, and indications for sedation precluded meta-analysis for any of the studies.…”

“…The characteristics of included studies can be found in Table 1 and included children undergoing dental procedures (n = 5) [21,22,[24][25][26], laceration repair (n = 1) [14], and gastric aspiration (n = 1) [23]. No quasi-randomized trials were eligible.…”

“…Two studies were judged to have high risk of bias for failing to report pre-specified outcomes [21,24] (Fig 2).…”

“…Four studies were deemed "favorable" because they reported adequate sedation in significantly more participants than the comparator [14,[22][23][24]. They involved IN ketamine as monotherapy (6 and 9 mg/kg) [14,22] or co-administered with IN midazolam (0.5 mg/kg) [23,24]. Among the two studies that used validated measures of sedation, Tsze et al found that only at a dose of 9 mg/kg did IN ketamine produce "adequate" sedation in all three participants undergoing laceration repair [14].…”

“…IN ketamine was co-administered with IN midazolam in two studies [23,24]. Both provided "favorable" sedation.…”