Abstract

There is largely an absence of validated evidence-based therapies in term- and preterm newborn infants, due to a lack of pharmacological clinical trials. As a consequence, the drugs and doses used in clinical practice are extrapolated from dose-ranging trials performed in older patients. Drugs administered to the preterm infant are invariably off-label. The aim of this current review is to identify commonly used anesthetic and analgesic agents in this patient population, assess the existing evidence base, in terms of safety, efficacy, pharmacokinetics and pharmacodynamics, current indications and doses. We searched the PubMed, Google Scholar, Web of Science, U.S. Food and Drug Administration and World Health Organization databases and analyzed any studies for general anesthesia; analgo-sedation; regional anesthesia; pharmacokinetics, pharmacodynamics and pharmacogenomics in this patient population. A total of 412 studies (meta-analysis, systematic reviews, randomized controlled trial (RCT), and observational) were identified and analyzed. Preterm infants are characterized by remarkable metabolic and developmental differences when compared with adults. It is not possible to derive guidelines or clinical recommendations based on the existing evidence.

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