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158 A Systematic Review of Pharnmacokinetics (Pk) of Dobutamine for use in Neonates and Children
  1. GS Shah1,
  2. D Crook2,
  3. H Rojas-Anaya3,4,
  4. H Rabe
  1. 1Paediatric Academic Department, Brighton and Sussex Medical School
  2. 2Clinical Investigations and Research Unit
  3. 3Paediatric Academic Department, Brighton and Sussex University Hospitals
  4. 4Paediatric Academic Department, Brighton and Sussex University Hospitals, Brighton and Sussex Medical School, Brighton, UK

Abstract

Background Dobutamine has been used off-label in newborns and children for treating haemodynamic insufficiency for over 20 years. As preparation for a large randomised study to achieve Paediatric Use Marketing Authorisation for dobutamine in newborns we performed a structured literature review of PK data.

Methods Structured searches were conducted using the electronic databases Medline and Embase. Search terms included dobutamine, infant, newborn, paediatric/pediatric, prematurity, child, infant, low birth weight infant, preschool child, school child, adolescent, pharmacokinetics, clinical pharmacology. Data was extracted based on pre-defined criteria decided by the team.

Main results Six of eleven papers emerging from this search met our inclusion criteria. These reported dobutamine PK data in a combined total of 70 children (age range 0 days-22 years, 13 newborns, 27–42 weeks gestation), with infusion rates ranging from 0.5–20 µg/kg/min. Five papers found that the infusion rate was positively correlated to plasma dobutamine concentration. Dobutamine clearance rates showed great variability between individuals (range 35.1–482.2 mL/kg/min). Four papers found that clearance did not vary with infusion rate, suggesting first order kinetics, although one paper (n=12) showed a significantly negative relationship (p<0.001) of dobutamine clearance to steady-state plasma concentration (dobutamine dosage 2–15 µg/kg/min).

Conclusions The current dobutamine PK data is difficult to interpret due to inhomogeneity and variability of patients’ age and conditions, dobutamine dosages and study designs. High quality prospective PK data -especially in newborns- is urgently required prior to our large randomised study.

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