Ketamine Sickle Cell Disease
- Registration Number
- NCT03502421
- Lead Sponsor
- University of South Florida
- Brief Summary
Sickle cell disease (SCD) often results in acute vaso-occlusive crisis (VOC), an obstruction of blood vessels resulting in ischemic injury and pain. The pain experienced during these episodes is due to a wide range of pathophysiological processes. Though recent studies have begun to unravel the underlying mechanisms of these processes, literature focused on pain management for sickle cell disease is scarce. Opioids and non-steroidal anti-inflammatory drugs (NSAIDs) remain the predominate treatment for VOC.
However, the efficacy of these treatments has come into question. A large sub-set of patients with SCD report continued pain despite treatment with opioids. Tolerance and opioid-induced hyperalgesia (OIH) may be responsible for unresponsiveness to opioid-centric treatment modalities. New classes of drugs are being tested to prevent and treat acute pain associated with SCD, but in the meantime physicians are looking to existing therapies to bridge the gap.
The N-methyl-d-aspartate (NMDA) receptor has been implicated in both tolerance and OIH. As a NMDA receptor agonist, ketamine has been shown to modulate opioid tolerance and OIH in animal models and clinical settings. Ketamine utilized as a low dose continuous infusion could benefit patients with SCD related pain that are unresponsive to opioid analgesics. Based on limited studies of adjuvant ketamine use for pain management, low-dose ketamine continuous infusion appears safe. Further clinical investigations are warranted to fully support the use of low-dose ketamine infusion in patients with SCD-related pain.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Subjects diagnosed with sickle cell anemia
- Adults aged 18 and older
- Subjects who have given written consent
- Subjects who are pregnant
- Subjects younger than 18 years
- Subjects known or suspected to have an allergy to opiates/opioids, muscle relaxants or other similar medications
- Subjects who have a contraindication to ketamine
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ketamine Ketamine Continuous infusion of Ketamine 0.3 to 0.5 mg/kg per hour PCA Dilaudid 2.0-2.5 mg
- Primary Outcome Measures
Name Time Method Total opioid Use in milligrams morphine equivalents 1-3 hours Total opioid Use in milligrams morphine equivalents
Pain scores measured on the Visual Analog Scale 0 - 10 1-3 hours Pain scores measured on the Visual Analog Scale 0 - 10
- Secondary Outcome Measures
Name Time Method Length of hospital stay 1-7 days Length of stay in the hospital
Cost of pharmacotherapy 1 day monetary cost of intervention used
Nausea and vomiting scores Visual Analog Scale 0 - 10 1-3 hours Nausea and vomiting scores Visual Analog Scale 0 - 10