Assessment of Clonidine Orally Disintegrating Tablet for Pre-anesthetic Medication in Pediatric Surgery

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. Fourtee...

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Bibliographic Details
Published in:Biological & Pharmaceutical Bulletin 2006, Vol.29(2), pp.321-323
Main Authors: Homma, Masato, Sumiya, Kenji, Kambayashi, Yasuyuki, Inomata, Shin-ichi, Kohda, Yukinao
Format: Article
Language:English
Subjects:
Administration, Oral
Biological Availability
Child
Child, Preschool
Clonidine - administration & dosage
Clonidine - blood
Clonidine - therapeutic use
Female
Hemodynamics - drug effects
Humans
Hypnotics and Sedatives - administration & dosage
Hypnotics and Sedatives - blood
Hypnotics and Sedatives - therapeutic use
Infant
Male
orally-disintegrating tablet
pediatric sugery
plasma clonidine concentration
pre-anesthetic sedation
Preanesthetic Medication - methods
Solubility
Surgical Procedures, Operative
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Summary: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 μg/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 patients 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
ISSN:0918-6158
1347-5215
DOI:10.1248/bpb.29.321