The purpose of this research is to see if ketamine is effective and safe in treating children and young adults with sickle cell disease experiencing sickle cell related pain. In this study, we will compare the outcomes (such as pain scores) in persons who receive standard of care pain medicine (an opioid such as morphine) plus a low dose (amount) of ketamine to those who receive only standard of care pain medicine.
Between the ages 5-20 years
Diagnosed sickle cell disease. Homozygous (HbSS) or heterozygous (HbSC, HbSBetaThal Plus or Zero) will be included.
Presenting with VOE pain, requiring IV pain medication.
First dose of analgesic medication is given before patient approached for participation in the study.
Sickle cell trait only
Patients whose primary language is other than English or Spanish
Pain attributed to causes other than VOE
Not requiring IV for pain treatment
Parallel
Sub-dissociative Ketamine Infusion
Drug0.25 mg/kg of IV ketamine within a 20-minute infusion of 100 milliliters of normal saline (NS)
Normal Saline Placebo Infusion
Drug20-minute infusion of 100 milliliters of normal saline
Total Opioid Medications Required for Analgesia
Cumulative morphine-mg equivalent per kilogram (MME/kg) of opioid medication needed to achieve a pain score of ≤ 5
Pain Score
Pain score from 0-10, at 30 and 60 minutes after administration of NS/placebo (control group), versus sub-dissociative ketamine (experimental group)
ED Length of Stay
To compare ED length of stay between control vs experimental group
Rate of Hospitalization
To compare rate of hospitalization and length of hospitalization between control and experimental group
Quality of Life (Pediatric Quality of Life)
To compare overall quality of life between the two groups upon discharge from the ED or the hospital, using the Pediatric Quality of Life (PedsQL) questionnaire. The questionnaire has 43 points and is reverse scored and linearly transformed to a 0-100 scale (0=100, 1=75, 2=50, 3=25, 4=0), so that higher scores indicate better quality of life.
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Mohsen Saidinejad
Lead sponsor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Sponsor institution
