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Optimising intravenous salbutamol in children: a phase 2 study
Sandra Walsh1, Shan Pan2, Yucheng Sheng2
1Paediatric and Neonatal Intensive Care Unit, Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK swalshieis@hotmail.com.
Archives of Disease in Childhood
|December 29, 2022
Summary
Developing a pharmacokinetic-pharmacodynamic (PKPD) model for salbutamol in children with asthma provides dosing guidance. A 0.5 µg/kg/min infusion after bolus achieves effective bronchodilation with minimal adverse effects.
Area of Science:
- Pediatric Pharmacology
- Pharmacometrics
- Respiratory Medicine
Background:
- Salbutamol (a beta-2 agonist) is a primary treatment for childhood asthma.
- Current pharmacokinetic-pharmacodynamic (PKPD) models for guiding pediatric salbutamol dosing are insufficient.
Purpose of the Study:
- To develop a PKPD model for salbutamol in children.
- To explore the relationship between salbutamol dose, serum concentration, effectiveness, and adverse effects in pediatric asthma patients.
Main Methods:
- A prospective cohort study involving children (1-15 years) hospitalized with acute asthma receiving intravenous salbutamol.
- Collected serial salbutamol plasma levels, Paediatric Asthma Severity Score (PASS), and toxicity measurements (lactate, pH, glucose, heart rate, blood pressure, arrhythmias).
- Utilized non-linear mixed-effect models for PKPD analysis.
Main Results:
- A two-compartment PK model accurately described salbutamol concentrations.
- An EMAX (maximum drug effect) model linked concentration to PASS and toxicity.
- PKPD simulations indicated that a 0.5 µg/kg/min infusion for 4 hours post-bolus provides over 90% maximal bronchodilation for 12 hours.
Conclusions:
- A pediatric PKPD model for salbutamol has been established.
- An infusion rate of 0.5 µg/kg/min following a bolus dose is effective for bronchodilation.
- Higher infusion rates are linked to increased tachycardia and hyperglycemia.
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