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Two propofol formulations are equivalent in small children aged 1 month to 3 years

K Pessenbacher1, A Gutmann, U Eggenreich

  • 1Department of Anesthesiology and Intensive Care, Karl-Franzens-University Graz, Austria. laus.pessenbacher@klinikum-graz.at

Acta Anaesthesiologica Scandinavica
|April 10, 2002
PubMed

Insights

Two propofol 1% emulsions demonstrated equivalent efficacy and safety in pediatric patients aged 1 month to 3 years undergoing anesthesia. This study provides crucial data for propofol use in young children.

Area of Science:

  • Anesthesiology
  • Pediatric Anesthesia
  • Pharmacology

Background:

  • Propofol is a common anesthetic agent, frequently used in pediatric anesthesia.
  • Limited scientific evidence exists for propofol use in children under 3 years old.
  • This study addresses the evidence gap for propofol in this vulnerable age group.

Purpose of the Study:

  • To compare the therapeutic equivalence of two propofol 1% emulsions (Propofol 1% Fresenius vs. Diprivan 1%).
  • To evaluate the safety profiles of these two propofol formulations in pediatric patients.
  • To establish evidence for propofol use in children aged 1 month to 3 years.

Main Methods:

  • Prospective, randomized, double-blind, therapeutic equivalence study.
  • 60 pediatric patients (1 month to 3 years) undergoing routine surgery or diagnostic laparoscopy.
  • Stratified randomization by age (<12 months and 12 months-3 years); analysis of induction and infusion doses, and side-effect profiles.

Main Results:

  • No significant differences in baseline characteristics between the two treatment groups.
  • Comparable medications for anesthesia induction/maintenance and side-effect profiles.
  • Equivalent average propofol doses for induction (4.0-4.2 mg/kg) and maintenance (8.74-9.42 mg·kg⁻¹·h⁻¹).

Conclusions:

  • Both 1% propofol formulations are equally effective in infants and young children (1 month-3 years).
  • No differences observed in circulatory reaction, lipid metabolism, dosages, or recovery.
  • The findings support the therapeutic equivalence and safety of the studied propofol emulsions in pediatric anesthesia.
Abstract

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