Pre-medication before dental procedures: A randomized controlled study comparing intranasal dexmedetomidine with oral midazolam.

Abstract

This study aimed to determine if intranasal dexmedetomidine is a superior pre-medication to oral midazolam in older, difficult children. This was conducted as a prospective, single-blind randomized control trial in a tertiary care center. Seventy-five children, age >5 years and weight >20 kg, who needed general anesthesia for dental procedures were randomly assigned to be pre-medicated with either oral midazolam at a dose of 0.5 mg/kg (max 15 mg) or intranasal dexmedetomidine at a dose of 2 mcg/kg (max 100 mcg). The primary outcome studied was the patients' level of sedation when separated from their parents, which was assessed using a 5-point University of Michigan Sedation Scale. Secondary outcome studied was the level of anxiolysis assessed by the acceptance of mask induction using a 4-point scale. All assessments were made by one research person blinded to the study drug. The two groups were similar in age, sex, weight, pre-anesthetic behavior, time from pre-medication to anesthesia induction, and surgical time. A significantly higher proportion of patients who received dexmedetomidine had satisfactory sedation at separation from parents (69.4% vs 40.5%, P = .03) compared to those who received midazolam. There were no significant differences in the rate of acceptance of mask induction (80.6% vs 78.4%, P = 1.00). Intranasal dexmedetomidine was tolerated well when administered using a mucosal atomizer and without any clinically significant effect on heart rate or systolic blood pressure. Intranasal dexmedetomidine provides higher success rate in sedation and parental separation compared to oral midazolam, in older, difficult children.