Comparing Intranasal and Oral Midazolam as Premedication in Paediatric Anaesthesia – A double-blind randomized control trial

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VM Yuen^1,2, TW Hui^1,2, MK Yuen^1,2, M Irwin¹
1Department of Anaesthesiology, University of Hong Kong. 2Department of Anaesthesiology, Queen Mary Hospital, Hong Kong.

Purpose of Study

Midazolam is the most commonly used premedication in paediatric population. It was shown to be more effective than parental presence or placebo in reducing anxiety and improving compliance at induction of anaesthesia (1). Clonidine, an a2 agonist, has been suggested to be a good alternative to midazolam as premedication in children (2). Dexmedetomidine, an a2 agonist with shorter half-life, may be a suitable premedication in children prior to induction of anaesthesia. This randomized double blind controlled trial was designed to evaluate whether intranasal dexmedetomidine is as effective as midazolam as preoperative premedication in children.

Method

After approval by the Institutional Review Board and obtaining informed consent from parents, ninety-six children of ASA physical status I or II scheduled for elective minor surgery were randomly assigned to one of the three groups. Group M received midazolam 0.5mg/kg in paracetamol syrup and intranasal placebo. Group D0.5 and Group D1 received intranasal dexmedetomidine 0.5μg/kg or 1μg/kg respectively and paracetamol syrup. Patients’ sedation status, behaviour scores, blood pressure, heart rate and oxygen saturation were recorded by an observer until induction of anaesthesia was commenced. Behaviour score and sedation status at induction, wake up behaviour score and time ready for discharge from recovery were also recorded.

Result

There were no significant differences in the parental separation acceptance, behaviour score at induction and wake up behaviour score (table 1). When compared with group M, patients in group D0.5 and D1 were significantly more sedated when they were separated from their parents (P<.001). Patients from D1 were significantly more sedated at induction of anaesthesia when compared with group M (P=0.016). The mean time ready for discharge from recovery room were significantly longer in group M when compared with group D0.5 and D1 (P=0.008) (table 1).

Conclusions

Intranasal dexmedetomidine at doses of 0.5μg/kg and 1μg/kg are as effective as oral midazolam as premedication in children prior to induction of anaesthesia. Moreover, it does not prolong recovery time.

References

1. Kain ZN, Mayes LC, Wang SM, Caramico L, Hofstadter MB. Parental presence during induction of anesthesia versus sedative premedication: which intervention is more effective? Anesthesiology 1998; 89: 1147-56.

2. Bergendahl H, Lonnqvist PA, Eksborg S. Clonidine in paediatric anaesthesia: review of the literature and comparison with benzodiazepines for premedication. Acta Anaesthesiol Scand 2006; 50: 135-43.

Time of Presentation
0830