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.