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Ketamine Sickle Cell Disease

A Randomized Controlled Trial to Determine the Efficacy of Ketamine as an Adjunct for Pain Management in Patients With Sickle Cell Crisis

Status
Withdrawn
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03502421
Acronym
SCD
Enrollment
0
Registered
2018-04-18
Start date
2018-09-01
Completion date
2019-11-01
Last updated
2018-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Chronic, SC Disease

Keywords

Ketamine

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.

Interventions

DRUGKetamine

Low dose continuous infusion of ketamine 0.3 to 0.5 mg/kg per hour

Sponsors

University of South Florida
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Randomized Controlled Prospective Clinical Trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Subjects diagnosed with sickle cell anemia * Adults aged 18 and older * Subjects who have given written consent

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Total opioid Use in milligrams morphine equivalents1-3 hoursTotal opioid Use in milligrams morphine equivalents
Pain scores measured on the Visual Analog Scale 0 - 101-3 hoursPain scores measured on the Visual Analog Scale 0 - 10

Secondary

MeasureTime frameDescription
Cost of pharmacotherapy1 daymonetary cost of intervention used
Length of hospital stay1-7 daysLength of stay in the hospital
Nausea and vomiting scores Visual Analog Scale 0 - 101-3 hoursNausea and vomiting scores Visual Analog Scale 0 - 10

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026