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Electrophysiological Measurements and Analysis of Nociception in Human Infants
Published on: December 20, 2011
Evaluating Gabapentin Dosing, Efficacy and Safety in Infants
Lauren Fleser1, Erin Tibbetts1, Alison Hanson1
1Department of Pharmacy (LF, ET, AH, ECC, KG, CT), Boston Children's Hospital, Boston, MA.
Insights
Gabapentin is safe and effective for infants, improving weight and reducing pain scores with few side effects. This study provides dosing guidance for pediatric neuropathic pain and irritability management.
Area of Science:
- Neonatal and Pediatric Pharmacology
- Pain Management
- Neurology
Background:
- Gabapentin use in infants for conditions like neuropathic pain and irritability has increased.
- Limited guidance exists for pediatric gabapentin dosing and outcomes.
- This study addresses the need for evidence-based practices in infant gabapentin management.
Purpose of the Study:
- To describe gabapentin dosing trends in infants.
- To identify efficacy outcomes, including pain and feeding.
- To characterize gabapentin weaning practices in a pediatric population.
Main Methods:
- Retrospective single-center study of infants (<1 year) receiving gabapentin (2015-2021).
- Primary outcome: indication, initiation, and maximum gabapentin dose.
- Secondary outcomes: mortality, adverse events, weight-for-age Z-scores, and FLACC scores.
Main Results:
- Sixty-six infants received gabapentin; common indications included irritability and visceral hyperalgesia.
- Mean initiation dose: 8.6 mg/kg/day; maximum mean dose: 23.2 mg/kg/day.
- Significant improvement in weight-for-age Z-scores and reduction in FLACC scores observed; three minor adverse events reported.
Conclusions:
- Gabapentin is well-tolerated in infants.
- Initial dosing of 5 mg/kg/dose every 24 hours is safe and aligns with existing literature.
- Gabapentin shows a beneficial role in improving infant outcomes with minimal adverse events.
Objective:
Gabapentin for management of neuropathic pain, irritability, neonatal abstinence syndrome, rescue sedation, feeding intolerance and visceral hyperalgesia in infants has grown over the past decade. There remains little guidance for indications, initiation, titration and maintenance dosing trends and assessment of outcomes. The primary objective was to describe gabapentin dosing, and the secondary objectives were to identify outcomes to assess efficacy and describe weaning practices.
Methods:
A retrospective single-center study was performed in infants younger than 1 year who received gabapentin at Boston Children's Hospital between 2015 and 2021. The primary outcome was indication, initiation and maximum gabapentin dose. Secondary outcomes included mortality, adverse reactions and impact on feeding volumes, weight-for-age Z-scores and face, legs, activity, cry, consolability (FLACC) scores. Descriptive statistics were utilized.
Results:
Sixty-six infants received gabapentin at a mean ± SD age of 5.5 ± 2.7 months (range of 0-11 months). The mean ± SD initiation dose of gabapentin was 8.6 ± 5.4 mg/kg/day with a median interval of 24 hours (8-24 hours). The maximum mean dose was 23.2 ± 14.4 mg/kg/day at a median interval of every 8 hours (8 hours). The most common indications for initiation were irritability, rescue sedation, and visceral hyperalgesia. There was a statistical improvement in weight-for-age Z scores from 24 hours prior to gabapentin initiation to 2 weeks after the maximum dose of gabapentin (-2.23 ± 1.78 to -1.66 ± 1.91, p < 0.001) and a reduction in FLACC scores (2.29 ± 1.64 to 1.52 ± 1.76, p = 0.007) from 24 hours prior to gabapentin initiation to 3 days after the maximum dose of gabapentin. Three patients experienced minor adverse events.
Conclusions:
Gabapentin was well tolerated in infants. Initial gabapentin dosing of 5 mg/kg/dose every 24 hours appears safe and consistent with other published studies in infants. The improvement in outcomes with few adverse events suggests a beneficial role for gabapentin.
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