Gabapentin for acute pain in sickle cell disease: A randomized double‐blinded placebo‐controlled phase II clinical trial
Latika Puri, Kerri Nottage, Jane S. Hankins, Winfred C. Wang, O. R. McGregor, Jeffrey M. Gossett, Guolian Kang, Doralina L. Anghelescu
Abstract
Abstract Pain in sickle cell disease (SCD) can have a neuropathic component. This randomized phase II double‐blinded placebo‐controlled study evaluated the efficacy of gabapentin in reducing pain and opioid consumption (morphine‐equivalent dose [MED]) during acute vaso‐occlusive crisis (VOC). Of 90 patients aged 1–18 years with VOC pain, 45 were randomized to a single gabapentin dose (15 mg/kg) and 45 to placebo, in addition to standard treatment; 42 and 44 patients were evaluable in the gabapentin and placebo arms, respectively. A decrease in pain of ≥33% was reported in 68% of patients in the gabapentin arm and 60% of those in the placebo arm (one‐sided p = 0.23). The median MED (mg/kg) in the gabapentin (0.12) and placebo arms (0.13) was similar ( p = 0.9). However, in the subset of patients with the HbSS genotype ( n = 45), the mean (SD) absolute pain score decrease by the time of discharge was significantly greater in the gabapentin arm (5.9 [3.5]) than in the placebo arm (3.6 [3.3]) ( p = 0.032). Pain scores in the overall study population were not significantly reduced when gabapentin was added to standard treatment; however, gabapentin benefited individuals with the more severe genotype, HbSS, during acute VOC. Larger, prospective studies are needed to confirm these findings.