Abstract
Introduction The disposition of phenobarbital in newborns may be affected by developmental changes in PK, treatment modalities and other factors. Phenobarbital treatment ultimately requires therapeutic monitoring (TDM) to optimize treatment.
Objective The purpose of this literature search was to obtain information on the primary (efficacy) and secondary (safety) parameters of phenobarbital and dosing regimen recommendations in this population.
Methodology Systematic literature search in PubMed, EMBASE, Web of Science, MEDLINE (March 1977– March 2023). Articles were marked as relevant if they included PK and parameters of efficacy and safety.
Results 49 relevant original articles were identified, of which 8 were conducted under hypothermic environment. Study cohorts were stratified into 76 subgroups (according to demographics, modality). PK was studied in 41%, the efficacy (seizure modification) of phenobarbital alone in 52%, and with co-medications in 51%. The safety of the treatment was described in 49% (bradycardia was noted 4 times, hypotension 7 times, oversedation 5 times, and respiratory depression 7 times. Plasma concentrations were measured in 82%. A dosing regimen was recommended in 47%, but dosage regimen validated in only 1%.
Conclusion Most studies focused on both PK parameters, and dose adjustments, while the efficacy and safety parameters still vary among the centers.
