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Department of Anesthesiology, Emory University School of Medicine, Childrens Healthcare of Atlanta, Atlanta, Georgia
Address correspondence to Keith K. Brosius, MD, Childrens Healthcare of Atlanta at Egleston, 1405 Clifton Rd., NE, Atlanta, GA 30322. Address e-mail to keith_brosius{at}emoryhealthcare.org Reprints will not be available from the authors.
We compared two available oral formulations of midazolam with respect to sedation score and plasma midazolam levels in pediatric surgical patients 210 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 III 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. Observers 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 Observers 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.
IMPLICATIONS: IV midazolam mixed in Syrpalta® syrup produces a greater sedative effect and higher plasma midazolam levels than the commercially available syrup when used as an oral anesthetic premedication in pediatric surgical patients.
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Bioavailability of Oral Midazolam Solutions Journal Watch Emergency Medicine, March 12, 2003; 2003(312): 5 - 5. [Full Text] |
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