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

Saad A Sheta, Maha A Al-Sarheed, Ashraf A Abdelhalim
Paediatric Anaesthesia 2014, 24 (2): 181-9

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.

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Tom Elwood

Despite the fact that dexmedetomidine causes prolonged sedation, three measures of recovery times were identical after 100' surgery duration. (table 3)


Tom Elwood

1 mcg/kg Slower onset (20-40') than midazolam, but less pain, less shivering postop.


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