Pain Management in Children and Young Adults With Sickle Cell Disease
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Intervention: Gabapentin; Placebo
Intervention description: Gabapentin is supplied as an oral suspension. Patients randomized to the gabapentin arm will receive a single dose of gabapentin as soon after enrollment as feasible. The gabapentin dose will be given orally and will be approximately 15 mg/kg with a maximum dose of 900 mg.; Placebo will be prepared by the SJCRH pharmacy and will be similar in appearance, quantity and taste to the gabapentin drug. Patients randomized to the placebo arm will receive a single dose of placebo as soon after enrollment as feasible. The placebo dose will be given orally and will be approximately 15 mg/kg with a maximum dose of 900mg.
Intervention MeSH terms: Gabapentin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 90.0
Sex: All
Minimum age: 1 Year
Maximum age: 20 Years
Healthy volunteers: No
Keywords: Pain control

Summary:

      This is a phase II double-blind placebo-controlled clinical trial evaluating the effect of
      gabapentin when added to standard pain management for patients with sickle cell disease
      experiencing acute pain crisis in the ambulatory care setting.

      Sickle cell pain is different for every patient. Some patients get complete relief from
      routine pain medicines, and others need more time or more doses of pain medicines before the
      pain goes away completely. It is known that humans have many types of pain, including
      something called neuropathic pain. Neuropathic pain in other conditions (such as diabetes)
      has been treated successfully with a medicine called gabapentin. The investigators in this
      study suspect that some sickle cell pain is a combination of pain types. They would like to
      see if adding gabapentin to the usual pain medicines makes pain go away faster or more
      completely.

      Primary Objective:

        -  To assess the analgesic efficacy of gabapentin vs. placebo for pain during
           vaso-occlusive crisis (VOC) in participants with sickle cell disease (SCD). A response
           to study drug will be defined by a decrease in pain score of ≥ 33% between presentation
           to the acute care setting and assessment at 3 hours post administration of study drug.

      Secondary Objective:

        -  To compare the total morphine equivalent dose (mg/kg) used to control pain during VOC
           between presentation to the acute care setting and assessment at 3 hours post
           administration of study drug in the gabapentin vs. placebo groups.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant must have sickle cell disease (any genotype) documented in the St. Jude
             medical record.

          -  Participant must be seeking care for acute vaso-occlusive pain at St. Jude Children's
             Research Hospital.

          -  Participant age must be ≥1 year and <21 years.

        Exclusion Criteria:

          -  Prior randomization in this study.

          -  Mild pain (score <4) or pain for which treatment with opioid is not indicated.

          -  Pregnant or lactating female.

          -  Decreased glomerular filtration rate (GFT) (<60ml/min/1.73m^2) as estimated by the
             revised Schwartz equation.

          -  Current treatment with gabapentinoid drugs (gabapentin or pregabalin).

          -  Known seizure disorder.

          -  Current treatment with antiepileptic agents.

          -  Pain in combination with other clinical symptoms that require additional
             interventions, including fever with focus, acute chest syndrome, acute injury, or
             splenic sequestration.

          -  Allergy to gabapentin.

          -  Current participation in another research study with an investigational new
             drug/device (IND/IDE) agent.

          -  Inability or unwillingness of research participant or legal guardian/representative to
             give written informed consent.