A Comparative Evaluation of Intranasal Midazolam, Ketamine and their Combination for Sedation of Young Uncooperative Pediatric Dental Patients: A Triple Blind Randomized Crossover Trial

Abstract

Objective: The purpose of this study was to evaluate and compare the efficacy and safety of intranasal (IN)administration of midazolam (M), ketamine (K) and their combination (MK) to produce moderate sedation in young, uncooperative pediatric dental patients. Study design: In this three stage crossover trial forty five uncooperative ASA type-1 children, who required dental treatment, were randomly assigned to receive one of the three drugs/combination by IN route during three subsequent visits. The efficacy and safety of the agents were assessed by overall success rate and by monitoring of vital signs, respectively. Results: The onset of sedation was rapid with K as compared to M and MK. The difference was statistically significant(P<0.01) between K and M. The overall success rate was 89% with K, MK was 84% and 69% with M. The difference between the overall success rates of K and M was statistically significant (P<0.01). Vital signs were within physiological limits and there were no significant adverse effects with any medication.Conclusions: M, K and MK are safe and effective by IN route to produce moderate sedation for providing dental care to pediatric dental patients who have been otherwise indicated for treatment under general anesthesia.

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.…”

“…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].…”

“…Five studies reported onset of sedation [14,22,23,25,26], with means ranging from 3.6 to 11.6 minutes. Duration of sedation was reported in all studies and when IN ketamine was used as monotherapy, the means ranged from 7 to 69 minutes.…”

Non invasive methods of sedation in paediatric dentistry-a review

“…[9,10] However, this route may be unpredictable, and frustration often arises when children refuse to accept the sedative medication. [9,11] The oral route is the oldest and most economical of all routes of drug administration. It is also the most universally accepted method.…”