A Phase 2 interventional study of Sub-dissociative Ketamine Infusion and Normal Saline Placebo Infusion in Sickle Cell Disease, Vaso-Occlusive Pain Episode in Sickle Cell Disease and Ketamine Infusion, sponsored by Mohsen Saidinejad. Recruiting at 1 site in United States. Open to participants aged 5 Years to 20 Years. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Mohsen Saidinejad · Phase 2, Interventional, and Treatment
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.
1,103 studies on the registry are indexed under Anemia, Sickle Cell; 235 are open to participants now.
This study's planned enrollment of 120 is above the median of 40 across 750 interventional studies indexed under Anemia, Sickle Cell.
Browse Anemia, Sickle Cell studies →This is the only study on the registry with Mohsen Saidinejad as lead sponsor.
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Exclusion Criteria:
Participants receiving 0.25 mg/kg infusion of ketamine
Drug: Sub-dissociative Ketamine Infusion
Participants receiving 100 milliliters of normal saline
Drug: Normal Saline Placebo Infusion
0.25 mg/kg of IV ketamine within a 20-minute infusion of 100 milliliters of normal saline (NS)
20-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
Time frame: Up to 3 days
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)
Time frame: 30 minutes and 60 minutes after administration of placebo vs ketamine infusion
ED Length of Stay
To compare ED length of stay between control vs experimental group
Time frame: Up to 3 days
Rate of Hospitalization
To compare rate of hospitalization and length of hospitalization between control and experimental group
Time frame: Up to 1 month
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.
Time frame: 7-10 days after enrollment in the study and 4-6 weeks after enrollment in the study
Plan to share: No
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