Background: This study aimed to determine if intranasal dexmedetomidine is a superior pre-medication to oral midazolam in older, difficult children.
Methods: 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.
Results: 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.
Conclusions: Intranasal dexmedetomidine provides higher success rate in sedation and parental separation compared to oral midazolam, in older, difficult children.
Trial registration: ClinicalTrials.gov NCT02250703.
Keywords: behavioral disorder; developmental delay; dexmedetomidine; midazolam; pre-medication.
© 2019 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.