The purpose of this study is to assess orally-disintegrating (OD) tablet of clonidine hydrochloride (CL) for a pre-operative sedation in pediatric surgery. Sedation score and plasma CL concentration of OD formulation was compared with original preparation, CL lollipop, in pediatric patients. Fourteen patients (age: 3.9+/-2.3 years, weight: 16.9+/-5.0 kg) for OD group and 9 patients (age: 4.4+/-3.1 years, weight: 17.2+/-7.0 kg) for lollipop group received 4 microg/kg of CL preparation. Pre-operative sedation was evaluated by 5-point scoring systems at entering the operating room. Plasma CL concentrations were determined 120 min after administration of CL preparation. The changes in systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR) were also assessed before and after administration of CL preparation. Every patient in OD group had satisfactory sedation (sedation score: 2 and 3), whereas, 3 (33%) in lollipop group had unsatisfactory sedation (sedation score: 0 and 1). Plasma CL concentration in OD group was significantly higher than those in lollipop group (0.75+/-0.15 vs. 0.42+/-0.21 ng/ml, p<0.01). There was no significant difference in hemodynamic parameters (SBP, DBP and HR) between before and after administration of CL preparation in both OD and lollipop group. We conclude that OD is superior preparation of CL for pre-operative sedation in pediatric surgery.
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