Gabapentin was found to be safe and well-tolerated, and to be associated with reduced pain scores and agitation in neonates and infants treated for 2 weeks in the neonatal intensive care unit (NICU) for complex medical problems, according to a study published in Developmental Medicine & Child Neurology.

Adults and children are routinely treated with gabapentin to manage a wide range of pain conditions, irritability, and dystonia. However, there are limited available data regarding the drug’s safety and efficacy in newborns and infants.

In this single-center retrospective study, 16 patients (56% girls; mean birth weight, 1925 g) who were admitted to the NICU with multiple comorbidities were enrolled. Patients were treated with gabapentin (starting dose, 2.5-5 mg/kg/day; maximum dose, 35 mg/kg/day) between January 2015 and December 2017. Scores on the Neonatal Pain, Agitation and Sedation Scale (N-PASS) were used to assess average daily pain, and neurosedative medication adjustments and adverse events (AEs) were recorded and reviewed 14 days after initiation of gabapentin therapy.

At gabapentin initiation, patients had a median corrected gestational age of 44 weeks (range, 36-75 weeks). They were admitted for agitation (n=9), pain (n=6), and a movement disorder (n=1). A total of 13 participants had a neurologic diagnosis, and 10 were receiving multiple neurosedative medications at the start of therapy.

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After 2 weeks receiving gabapentin, 2 of 10 patients remained on ≥3 neurosedative medications (79% reduction; mean number of prescribed neurosedatives was reduced from 2.5 to 1.7 per day). The mean N-PASS score was reduced from 1.1±0.2 at baseline to 0.5±0.1 after 2 weeks of treatment (P =.003). Only 1 AE was reported (oversedation that led to a brief discontinuation), with all patients tolerating treatment well.

Study limitations include a small sample size, unavailability of an objective measure for agitation/irritability, requirement of a developmental pediatrician’s assessment before initiation of therapy, and a retrospective design that precludes causal inference.

“Our cohort adds to the growing evidence that gabapentin may be a useful therapy for neonates and infants with chronic agitation and pain,” noted the authors. They recommended that future research involve more pharmacokinetic studies and confirmation of their findings regarding the safety and efficacy of gabapentin in this population.

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Reference

Burnsed JC, Heinan K, Letzkus L, Zanelli S. Gabapentin for pain, movement disorders, and irritability in neonates and infants [published online July 25, 2019]. Dev Med Child Neurol. doi:10.1111/dmcn.14324