Midazolam premedication in children: a comparison of two oral dosage formulations on sedation score and plasma midazolam levels.

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.

RCT Entities:   Population Interventions Outcomes