Pharmacologic pain management in a high-complexity neonatal intensive care unit: real-world patterns of analgesic and sedative use in neonates

Abstract

Introduction Effective pain management in neonates remains a major challenge, with limited real-world data on the pharmacologic strategies used in NICUs. Untreated pain and suboptimal sedation in the neonatal period has been associated with adverse neurodevelopmental outcomes. The aim of this study was to describe real-world patterns of systemic sedatives and analgesics use in a level III NICU. Methods We conducted a 13-month retrospective observational study, including inborn infants admitted to the NICU for more than 24hours. We analyzed drug selection, administered doses, cumulative doses, route of administration, adverse events and management of drug withdrawal. Results During the study period, 423 newborn infants were admitted to the NICU, of whom 357 met the inclusion criteria. Among them, 53.2% (n=190) required sedation or analgesia. The median (IQR) duration of sedation/analgesia was 4.5 (2-11) days. Sedation was significantly more frequent among patients requiring mechanical ventilation (92.7% vs 35.9%, P <.005). Eighty-two infants received continuous opioid infusion, with fentanyl as the first choice (96.3%). Sixty-eight received dexmedetomidine, often in combination with midazolam (severe cases requiring deep sedation). Neuromuscular blockers were used in only five patients, primarily for extracorporeal membrane oxygenation or major surgeries. Adverse events, mainly hypotension or bradycardia occurred in 9.2% of the patients. Conclusions Our findings underscore the need for standardized, evidence-based protocols for analgesia and sedation in NICUs. Detailed documentation of real-world prescribing practices (including prescribed individual and cumulative doses) and safety outcomes may support safer pain management in vulnerable neonatal populations.