Pediatric anesthesia & critical care
Pharmacokinetic and Pharmacodynamic Modeling of Clonidine and Midazolam for Sedation in Pediatric Intensive Care
- prematurely terminated
Authors' conclusion
The CloSed data suggest that higher doses of clonidine and midazolam than are commonly used in clinical practice should be considered to provide adequate sedation in critically ill children.
Study context
- Population
- Mechanically ventilated children (0–6 years) in PICU, with morphine as background analgesia
- Participants
- 28 participants
- Comparison
- Clonidine vs midazolam for sedation
- Clonidinen = 15
- Midazolamn = 13
- Primary endpoint
- Concentration-effect relationship with COMFORT-B score as pharmacodynamic endpoint
Methodological detailssecondary analysis of the CloSed randomised trial, multicentre, double-blind, active-controlled, noninferiority, One-compartment model for clonidine; single compartment for midazolam and its metabolite; joint inhibitory sigmoid model with postanesthesia effect, 317 (midazolam) and 306 (clonidine) COMFORT-B scores available
- Secondary analysis of the CloSed randomised trial
- Multicentre
- Double-blind
- Active-controlled
- Noninferiority
- One-compartment model for clonidine; single compartment for midazolam and its metabolite; joint inhibitory sigmoid model with postanesthesia effect
- 317 (midazolam) and 306 (clonidine) COMFORT-B scores available
Primary result
As reported in the abstract
Simulated dose required for adequate sedation
- Clonidine: 4 μg/kg loading dose then 3 μg/kg/h infusion
- Midazolam: 200 μg/kg loading dose then 200 μg/kg/h infusion
- Final models adequately described the observed data
Original publication
Pharmacokinetic and Pharmacodynamic Modeling of Clonidine and Midazolam for Sedation in Pediatric Intensive Care. Paediatr Anaesth. Published 4 October 2025. doi:10. 1111/ pan. 70050
Composed by AI from the published abstract and checked against it. How Briefs are made →