Gabapentin for acute pain in sickle cell disease: A randomized double‐blinded placebo‐controlled phase II clinical trial

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.

Patient and clinician beliefs about potential barriers to treatment of neuropathic pain for adolescents with sickle cell disease

“…One small randomized controlled trial in adults with SCD compared pregabalin to placebo for impact on self-reported NP and quality of life, but limitations of small sample size, attrition, and short duration of the study limit meaningful conclusions [24,26]. In children with SCD, one trial randomized patients presenting with acute vaso-occlusive pain to gabapentin or placebo but did not include NP as a prerequisite for study inclusion or as a specific outcome measure [27]. However, case reports and anecdotal experience suggest that these interventions may alleviate some of the symptoms stemming from SCD-related NP in children and adolescents [28,29].…”