Median effective dosage of midazolam oral solution for preschool children in preoperative sedation

Area of Science:

• Pediatric Anesthesiology
• Pharmacology
• Sedation Therapeutics

Background:

• Preoperative sedation in preschool children requires precise dosing for safety and efficacy.
• Midazolam oral solution (MOS) is commonly used, but its optimal dosage for this age group needs further definition.
• Accurate ED50 determination is crucial for establishing safe and effective sedation protocols.

Purpose of the Study:

• To determine the median effective dose (ED50) of midazolam oral solution (MOS) for preoperative sedation in preschool children.
• To establish the 95% effective dose (ED95) and confidence intervals for MOS in this pediatric population.
• To provide evidence-based dosing guidelines for MOS in young children undergoing elective surgery.

Main Methods:

• A sequential method was employed to determine the ED50 of MOS in 30 preschool children (3-6 years old) undergoing elective surgery.
• Dosage adjustments were made based on sedation success criteria (Ramsay score ≥4, Frankl score ≥3) and absence of severe adverse events.
• Probit regression analysis was utilized to calculate ED50, ED95, and their 95% confidence intervals.

Main Results:

• The determined ED50 of MOS for preoperative sedation in preschool children was 0.627 mg/kg (95% CI: 0.582-0.669 mg/kg).
• The ED95 was calculated to be 0.795 mg/kg (95% CI: 0.712-1.211 mg/kg).
• Adverse events recorded included bradycardia, nausea, vomiting, and blurred vision, with no grade III or higher events observed.

Conclusions:

• The study established the ED50 and ED95 of midazolam oral solution for preoperative sedation in preschool children.
• These findings offer valuable reference data for the safe and effective administration of MOS in pediatric surgical patients.
• Precise dosing of MOS can optimize sedation efficacy while minimizing risks in young children.