Ketamine Sickle Cell Disease (SCD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03502421|
Recruitment Status : Withdrawn (Never IRB approved, no intention to proceed with the study)
First Posted : April 18, 2018
Last Update Posted : September 26, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|SC Disease Pain, Chronic||Drug: Ketamine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized Controlled Prospective Clinical Trial|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Controlled Trial to Determine the Efficacy of Ketamine as an Adjunct for Pain Management in Patients With Sickle Cell Crisis|
|Estimated Study Start Date :||September 1, 2018|
|Estimated Primary Completion Date :||September 1, 2019|
|Estimated Study Completion Date :||November 1, 2019|
Continuous infusion of Ketamine 0.3 to 0.5 mg/kg per hour PCA Dilaudid 2.0-2.5 mg
Low dose continuous infusion of ketamine 0.3 to 0.5 mg/kg per hour
No Intervention: Opioid Only
Patient-controlled analgesia Dilaudid 2.0-2.5 mg
- Total opioid Use in milligrams morphine equivalents [ Time Frame: 1-3 hours ]Total opioid Use in milligrams morphine equivalents
- Pain scores measured on the Visual Analog Scale 0 - 10 [ Time Frame: 1-3 hours ]Pain scores measured on the Visual Analog Scale 0 - 10
- Cost of pharmacotherapy [ Time Frame: 1 day ]monetary cost of intervention used
- Length of hospital stay [ Time Frame: 1-7 days ]Length of stay in the hospital
- Nausea and vomiting scores Visual Analog Scale 0 - 10 [ Time Frame: 1-3 hours ]Nausea and vomiting scores Visual Analog Scale 0 - 10
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03502421
|Principal Investigator:||Enrico Camporesi, MD||University of South Florida|