A comparison of intranasal dexmedetomidine and oral midazolam for premedication in pediatric anesthesia: a double-blinded randomized controlled trial.
BACKGROUND
Midazolam is the most commonly used premedication in children. It has been shown to be more effective than parental presence or placebo in reducing anxiety and improving compliance at induction of anesthesia. Clonidine, an alpha(2) agonist, has been suggested as an alternative. Dexmedetomidine is a more alpha(2) selective drug with more favorable pharmacokinetic properties than clonidine. We designed this prospective, randomized, double-blind, controlled trial to evaluate whether intranasal dexmedetomidine is as effective as oral midazolam for premedication in children.


METHODS
Ninety-six children of ASA physical status I or II scheduled for elective minor surgery were randomly assigned to one of three groups. Group M received midazolam 0.5 mg/kg in acetaminophen syrup and intranasal placebo. Group D0.5 and Group D1 received intranasal dexmedetomidine 0.5 or 1 microg/kg, respectively, and acetaminophen syrup. Patients' sedation status, behavior scores, blood pressure, heart rate, and oxygen saturation were recorded by an observer until induction of anesthesia. Recovery characteristics were also recorded.


RESULTS
There were no significant differences in parental separation acceptance, behavior score at induction and wake-up behavior score. When compared with group M, patients in group D0.5 and D1 were significantly more sedated when they were separated from their parents (P < 0.001). Patients from group D1 were significantly more sedated at induction of anesthesia when compared with group M (P = 0.016).


CONCLUSIONS
Intranasal dexmedetomidine produces more sedation than oral midazolam, but with similar and acceptable cooperation.
Yuen
Vivian M
VM
Department of Anaesthesiology, University of Hong Kong, Queen Mary Hospital, Hong Kong. vtang131@hku.hk
Hui
Theresa W
TW
Irwin
Michael G
MG
Yuen
Man K
MK
D000281:Administration, Intranasal; D000284:Administration, Oral; D000316:Adrenergic alpha-Agonists / Q000008:administration & dosage*; D001010:Anxiety, Separation / Q000517:prevention & control; D002648:Child; D002652:Child Behavior / Q000187:drug effects*; D002675:Child, Preschool; D003243:Consciousness / Q000187:drug effects*; D020927:Dexmedetomidine / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D006439:Hemodynamics / Q000187:drug effects; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage*; D008297:Male; D008874:Midazolam / Q000008:administration & dosage*; D010349:Patient Compliance; D011229:Preanesthetic Medication; D011446:Prospective Studies; D012107:Research Design; D012119:Respiration / Q000187:drug effects; D013997:Time Factors; D016896:Treatment Outcome
D000316:Adrenergic alpha-Agonists; D006993:Hypnotics and Sedatives; D020927:Dexmedetomidine; D008874:Midazolam