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Pharmacokinetics of midazolam in children: comparative study of intranasal and intravenous administration
1Département de Pharmacologie Périnatale et Pédiatrique, Hôpital Saint-Vincent de Paul, Paris, France.
Insights
Intranasal midazolam offers rapid absorption in children aged 1-5 years, comparable to intravenous routes. This study highlights intranasal midazolam as a viable alternative for pediatric sedation.
Area of Science:
- Pediatric Pharmacology
- Anesthesiology
- Pharmacokinetics
Background:
- Midazolam is a common sedative used in pediatric care.
- Intravenous (IV) administration requires specialized skills and can be painful for children.
- Alternative routes of administration are being explored to improve sedation delivery.
Purpose of the Study:
- To compare the pharmacokinetic profiles of midazolam administered via intranasal (IN) and intravenous (IV) routes in children.
- To evaluate the efficacy and safety of IN midazolam as a sedation method.
Main Methods:
- Twelve children aged 1-5 years were randomly assigned to receive midazolam 0.2 mg/kg via IV or IN routes.
- Plasma concentrations of midazolam were measured over time.
- Pharmacokinetic parameters including Tmax, half-life, clearance, and volume of distribution were calculated.
Main Results:
- Rapid absorption was observed after IN administration, with a Tmax of 12 minutes.
- The half-life of midazolam was similar for both IN (2.2 h) and IV (2.4 h) routes.
- Apparent plasma clearance and volume of distribution were approximately double after IN administration compared to IV.
- Mean bioavailability for the IN route was estimated at 55%.
Conclusions:
- Intranasal midazolam provides rapid absorption and achieves comparable plasma concentrations to IV administration in young children.
- The pharmacokinetic profile suggests IN midazolam is a feasible and effective alternative for pediatric sedation.
- Further research should explore clinical efficacy and broader safety profiles.
Abstract:
Twelve children 1-5 y old were randomly assigned to receive midazolam 0.2 mg.kg-1 either by the intravenous (IV) or intranasal (IN) routes. After IN administration the rapid onset of absorption was observed (tmax 12 min). After both routes of administration the half-life was similar (2.2 h IN and 2.4 h IV). After IN administration the apparent plasma clearance and volume of distribution were about twice as high as after IV administration. The results are consistent with an estimated mean bioavailability of 55%.