PURPOSE: Gabapentin, a gamma-aminobutyric acid (GABA) analog with antiepileptic and antinociceptive properties, is increasingly reported in the literature for the treatment of pain and agitation in medically complex patients in the neonatal intensive care unit (NICU), despite the paucity of safety and efficacy data in infants. The objectives of this study were to characterize gabapentin utilization in the NICU over time and describe clinical characteristics associated with gabapentin exposure in infants. These data will help inform study design for early phase trials of the pharmacokinetics and safety of gabapentin in infants. METHODS: This is a retrospective chart review using the Pediatrix Medical Group Clinical Data Warehouse, which includes >1,000,000 patients discharged from 388 NICUs in the United States. We included patients discharged from 2005 – 2018 who received ≥ 1 gabapentin dose during their hospitalization. We describe infant clinical characteristics, as well as timing of gabapentin exposure. RESULTS: A total of 120 infants discharged from Pediatrix centers from 2005 – 2018 were exposed to gabapentin. The number of patients exposed to gabapentin has increased markedly in recent years, with 103/120 (86%) of exposures occurring between 2016-2018. Gabapentin exposure occurred in 21/388 (5%) of sites, with 3 sites accounting for 65/120 (54%) of all exposures. In infants exposed to gabapentin, the median gestational age (GA) at birth was 37 weeks [interquartile range (IQR) 28 – 39], with median birth weight 2.57 kg (IQR 0.985 – 3.176). Term infants and extremely preterm infants born ≤ 25 weeks accounted for a majority (74%) of exposed infants. The median postnatal age of first gabapentin exposure was 60 days (IQR 29—103) (Table). Bronchopulmonary dysplasia (45/99, 45%), major congenital anomalies (25%), gastrostomy tube placement (37%), and tracheostomy placement (20%) were common comorbidities and interventions in infants exposed to gabapentin. Exposures to opioids (88%), benzodiazepines (58%), and alpha-2 agonists (43%) during hospitalization were also common in this cohort. All infants < 34 weeks GA received the first dose of gabapentin after 28 postnatal days, while 38% of infants ≥ 34 weeks GA received their first dose before 28 postnatal days (Figure). CONCLUSION: The trend of gabapentin use in NICUs has increased substantially since 2005, especially from 2016 – 2018. Three centers accounted for the majority of gabapentin utilization; however, both overall and site-specific use is increasing. Further studies evaluating dosing, safety, and efficacy of gabapentin in neonates are needed.

Table.

Demographics and Clinical Characteristics of Infants Exposed to Gabapentin

Table.

Demographics and Clinical Characteristics of Infants Exposed to Gabapentin

Close modal
Figure.

Postnatal Age at Time of First Gabapentin Exposure

Figure.

Postnatal Age at Time of First Gabapentin Exposure

Close modal