Intranasal dexmedetomidine vs midazolam for premedication in children undergoing complete dental rehabilitation: A double-blinded randomized controlled trial

Summary Background This prospective, randomized, double-blind study was designed to evaluate the use of intranasally administered dexmedetomidine vs intranasal midazolam as a premedication in children undergoing complete dental rehabilitation. Methods Seventy-two children of American Society of Anesthesiology classification (ASA) physical status (I & II), aged 3-6 years, were randomly assigned to one of two equal groups. Group M received intranasal midazolam (0.2 mg·kg-1), and group D received intranasal dexmedetomidine (1 μg·kg-1). The patients' sedation status, mask acceptance, and hemodynamic parameters were recorded by an observer until anesthesia induction. Recovery conditions, postoperative pain, and postoperative agitation were also recorded. Results The median onset of sedation was significantly shorter in group M 15 (10-25) min than in group D 25 (20-40) min (P = 0.001). Compared with the children in group M, those in group D were significantly more sedated when they were separated from their parents (77.8% vs 44.4%, respectively) (P = 0.002). Satisfactory compliance with mask application was 58.3% in group M vs 80.6% in group D (P = 0.035). The incidences of postoperative agitation and shivering were significantly lower in Group D compared with group M. Thirteen children (36.1%) in group M, showed signs of nasal irritation with teary eyes, and none of these signs was seen in the children in group D (P = 0.000). There were no incidences of bradycardia, hypotension, in either of the groups during study observation. Conclusion Intranasal dexmedetomidine (1 μg·kg-1) is an effective and safe alternative for premedication in children; it resulted in superior sedation in comparison to 0.2 mg·kg-1 intranasal midazolam. However, it has relatively prolonged onset of action. © 2013 John Wiley & Sons Ltd.