Resident Duke University Hospital Durham, North Carolina, United States
Background: The use of sedatives and analgesics in infants has been debated because of neurodevelopmental outcome concerns. Infants in the neonatal intensive care unit (NICU) may undergo 1-17 painful procedures daily and are without anesthesia 42-100% of the time. We previously showed sedative and analgesic use in end-of-life care in the NICU increased between 1997 and 2013. With increased recognition of neonatal pain, the landscape of sedative and analgesic use has likely changed. Objective: Describe changes in sedation and analgesic administration in end-of-life care in the NICU; determine infant characteristics associated with their administration. Design/Methods: We will conduct a cohort study using deidentified data from the Pediatrix Clinical Data Warehouse of infants hospitalized in >400 NICUs. We will include all inborn infants who died between 2013-2021 and received a sedative or analgesic during hospitalization.
Infants will be divided into 3 groups based on exposure to a drug of interest (opioids, benzodiazepines, central alpha 2 agonists, ketamine, pentobarbital): no exposure on the day of death, exposure on the day of death, and any exposure during hospitalization. We will use summary statistics to describe infant demographics and clinical characteristics. We will perform univariable logistic regressions to evaluate association between i) sedative and analgesic exposure on the day of death and at any time during hospitalization, and ii) the following variables: gestational age, postnatal age, race/ethnicity, sex, invasive procedure within 2 days of death, inotrope, antibiotic, and ventilator exposure on the day of death. For multivariable modeling, we will include covariates that may be clinically associated with sedative and analgesic exposure on the day of death, including random effects for NICU site. We will perform a sensitivity analysis and limit our cohort to infants admitted ≥2 days. The study has been approved by the Duke University Institutional Review Board. Data will be analyzed by December 2023, with project completion by January 2024.
