Pain Management in Children and Young Adults With Sickle Cell Disease

• Status: Completed
• Trial end date: 2018-01-03
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Jude Children's Research Hospital
• Collaborator: Scan | Design Foundation
• Treatments: Gabapentin; gamma-Aminobutyric Acid

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.