title: Assessment of clonidine orally disintegrating tablet for pre-anesthetic medication in pediatric surgery.
abstract: 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.
authors.affiliation: Department of Pharmaceutical Sciences, Graduate School of Comprehensive Human Sciences, University of Tsukuba, Tsukuba, Ibaraki 305-8575, Japan. masatoh@md.tsukuba.ac.jp
authors.forename: Masato
authors.initials: M
authors.lastname: Homma
authors.forename: Kenji
authors.initials: K
authors.lastname: Sumiya
authors.forename: Yasuyuki
authors.initials: Y
authors.lastname: Kambayashi
authors.forename: Shin-ichi
authors.initials: S
authors.lastname: Inomata
authors.forename: Yukinao
authors.initials: Y
authors.lastname: Kohda
mesh_terms: D000284:Administration, Oral; D001682:Biological Availability; D002648:Child; D002675:Child, Preschool; D003000:Clonidine / Q000008:administration & dosage / Q000097:blood / Q000627:therapeutic use; D005260:Female; D006439:Hemodynamics / Q000187:drug effects; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage / Q000097:blood / Q000627:therapeutic use; D007223:Infant; D008297:Male; D011229:Preanesthetic Medication / Q000379:methods*; D012995:Solubility; D013514:Surgical Procedures, Operative
chemical_list: D006993:Hypnotics and Sedatives; D003000:Clonidine