Pharmacokinetics and Safety of Endotracheal Lidocaine for Endotracheal Intubation in Critically III Children

• Published in: Paediatric drugs Vol. 27; no. 1; pp. 103 - 109
• Main Authors: Anderson, Jordan, Owen, Erin B, Mayes, Shannon, Sullivan, Janice E, McDonald, Mark J
• Format: Journal Article
• Language: English
• Published: Auckland Springer Nature B.V 01.01.2025
• Subjects: Anesthesia; Catheters; Childrens health; Clinical trials; Convulsions & seizures; Creatinine; Drug dosages; Enzymes; FDA approval; Hemoglobin; Immunoassay; Intensive care; Intubation; Laboratories; Metabolites; Ostomy; Pharmacokinetics; Suctioning; Toxicity
• ISSN: 1174-5878; 1179-2019

[...]a study in pediatrie traumatic brain injury demonstrated a blunted increase in ICP with endotracheal instillation of lidocaine (1.7 ± 0.3 mg/kg) compared with saline [12]. The assay is based on competi-tion of the drug in the patiënt specimen and the labeled marker with the enzyme glucose-6-phosphate dehydroge-nase (G6PDH) for antibody binding sites. Because enzyme activity decreases upon binding to the antibody, the drug concentration is measured in terms of enzyme activity. Secondary objectives included assessment of the rate and severity of adverse effects, such as seizure activity and depression of cardiac or respiratory function, and determination of the appropriate dosing of ETT lidocaine in infants and children. 2.2 Inclusion and Exclusion Criteria Subjects included in this study were aged > 38 weeks esti-mated gestational age (EGA) and <18 years, endotrache-ally intubated and mechanically ventilated, had no ETT lidocaine within 4 h before the study intervention, and had an approved access device in place for collection of blood samples. Potential subjects were also excluded if baseline laboratory values were not avail-able at the time of study inclusion, including AST, ALT, serum creatinine, and hemoglobin. 2.3 Study Design This prospective phase I clinical trial was designed to enroll 10 subjects aged > 38 weeks EGA and < 3 years (group 1) and 10 subjects aged 3-18 years (Group 2).