ABSTRACT
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.
ABSTRACT
PURPOSE: Patient safety enhancements achieved through the use of an automated i.v. compounding workflow management system are reported. SUMMARY: Automated systems integrating barcode verification of ingredients and the capture of serial images of all steps of the admixture process have the potential to improve the accuracy of parenteral i.v. medication dose preparation. About 18 months after the implementation of such a system at a large pediatric hospital, a retrospective analysis of dose preparation outcomes was conducted to evaluate the effectiveness of the i.v. workflow manager in detecting compounding errors and to categorize detected errors. In verifying the accuracy of 425,683 medication doses prepared during the approximately 13-month evaluation period, dispensing pharmacists detected preparation or documentation errors affecting 2,900 doses (0.68%); 1,223 of those doses (0.29%) required reworking, and 1,677 (0.4%) were rejected and destroyed. Roughly 23% of the detected errors were classified as undetectable via the pharmacy's previous verification practices, with 167 errors judged to pose the potential for adverse drug events resulting in moderate (n=146) or severe (n=21) harm. Among the reworked and rejected doses, 43.8% and 31.3%, respectively, were due to newly emergent problems not seen with traditional paper-based verification systems; however, most of these errors involved blurry or missing images and were not judged to be clinically significant. CONCLUSION: Implementation of an i.v. workflow management system that integrates barcode verification, automated calculations, and image-capture capabilities led to increased detection of errors in the sterile product compounding process.
