title: Midazolam premedication in children: a comparison of two oral dosage formulations on sedation score and plasma midazolam levels.
abstract: We compared two available oral formulations of midazolam with respect to sedation score and plasma midazolam levels in pediatric surgical patients 2-10 yr old. The commercially available oral syrup was compared with a mixture of the IV midazolam preparation in Syrpalta syrup at an equivalent concentration of 2 mg/mL. ASA status I-II patients were randomly assigned to receive 0.5 mg/kg of either the commercial syrup (Group 1) or the prepared mixture (Group 2) as anesthetic premedication. Observer's Assessment of Alertness/Sedation scores were obtained by a blinded observer at 15 and 30 min after drug administration. Plasma midazolam levels were acquired exactly 45, 60, and 90 min after administration. Group 2 patients had a significantly lower median Observer's Assessment of Alertness/Sedation score (Group 1, 17; Group 2, 15) at 30 min (P < 0.03) and significantly higher mean plasma midazolam levels at all three acquisition times (mean +/- SD) (45 min: 63.1 +/- 23.9 ng/mL, Group 2; 43.4 +/- 19.6 ng/mL, Group 1; 60 min: 45.8 +/- 18.2 ng/mL, Group 2; 30.8 +/- 17.9 ng/mL, Group 1; 90 min: 28.9 +/- 12.6 ng/mL, Group 2; 21.0 +/- 8.9 ng/mL, Group 1) (P < 0.02). We conclude that IV midazolam mixed in Syrpalta syrup yields more reliable sedation and correspondingly higher plasma levels than an equivalent dose of the commercially formulated and marketed preparation.
authors.affiliation: Department of Anesthesiology, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, Georgia 30322, USA. keith_brosius@emoryhealthcare.org
authors.forename: Keith K
authors.initials: KK
authors.lastname: Brosius
authors.forename: Carolyn F
authors.initials: CF
authors.lastname: Bannister
mesh_terms: D000284:Administration, Oral; D000769:Anesthesia, Inhalation; D001835:Body Weight / Q000187:drug effects; D002648:Child; D002675:Child, Preschool; D016292:Procedural Sedation; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage / Q000097:blood; D008297:Male; D008874:Midazolam / Q000008:administration & dosage / Q000097:blood; D019999:Pharmaceutical Solutions; D011229:Preanesthetic Medication
chemical_list: D006993:Hypnotics and Sedatives; D019999:Pharmaceutical Solutions; D008874:Midazolam