• Paediatric anaesthesia · Nov 2010

    Multicenter Study

    A novel isotonic-balanced electrolyte solution with 1% glucose for intraoperative fluid therapy in children: results of a prospective multicentre observational post-authorization safety study (PASS).

    • Robert Sümpelmann, Thomas Mader, Christoph Eich, Lars Witt, and Wilhelm A Osthaus.
    • Medizinische Hochschule Hannover, Klinik für Anästhesiologie und Intensivmedizin-OE 8050, Hannover, Germany. suempelmann.robert@mh-hannover.de
    • Paediatr Anaesth. 2010 Nov 1;20(11):977-81.

    BackgroundThe recommendations for intraoperative fluid therapy in children have been adapted from hypotonic to isotonic electrolyte solutions with lower glucose concentrations (1-2.5% instead of 5%) to avoid hyponatremia and hyperglycemia.ObjectiveThe objective of this prospective multicentre observational post-authorization safety study was to evaluate the intraoperative use of a novel isotonic-balanced electrolyte solution with 1% glucose (BS-G1) with a particular focus on changes in acid-base status, electrolyte and glucose concentrations.MethodsFollowing local ethics committee approval, pediatric patients aged up to 4 years with an ASA risk score of I-III undergoing intraoperative administration of BS-G1 were enrolled. Patient demographics, the performed procedure, adverse drug reactions, hemodynamic data, and the results of blood gas analysis before and after infusion were documented with a focus on changes in acid-base status, electrolyte and glucose concentrations.ResultsIn 107 patients (ASA I-III; age 16.2 ± 15.4, range day of birth to 47.7 months; body weight 8.8 ± 4.8, range 1.6-18.8 kg), the mean volume infused was 20 ± 12.6 (range 3.6-83.3) ml·kg(-1) BS-G1. During the infusion, hemoglobin, hematocrit, anion gap, strong ion difference, and calcium decreased and chloride and glucose increased significantly within the physiologic range. All other measured parameters including sodium, bicarbonate, base excess, and lactate remained stable. Neither hypoglycemia (glucose <2.5 mmol·l(-1) ) nor hyperglycemia (glucose >10 mmol·l(-1) ) was documented after BS-G1 infusion. No adverse drug reactions were reported.ConclusionThe studied isotonic-balanced electrolyte solution with 1% glucose helps to avoid perioperative acid-base imbalance, hyponatremia, hyperglycemia, and ketoacidosis in infants and toddlers and may therefore enhance patient safety.© 2010 Blackwell Publishing Ltd.

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