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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sub-dissociative Ketamine | Experimental | Participants receiving 0.25 mg/kg infusion of ketamine |
|
| Normal Saline | Placebo Comparator | Participants receiving 100 milliliters of normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sub-dissociative Ketamine Infusion | Drug | 0.25 mg/kg of IV ketamine within a 20-minute infusion of 100 milliliters of normal saline (NS) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 30 minutes and 60 minutes after administration of placebo vs ketamine infusion |
| ED Length of Stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cynthia Luo, MD | Contact | 310-222-2345 | cluo2@dhs.lacounty.gov | |
| Mohsen Saidinejad, MD | Contact | moh@emedharbor.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harbor UCLA Medical Center | Recruiting | Torrance | California | 90509 | United States |
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| Normal Saline Placebo Infusion | Drug | 20-minute infusion of 100 milliliters of normal saline |
|
To compare ED length of stay between control vs experimental group |
| Up to 3 days |
| Rate of Hospitalization | To compare rate of hospitalization and length of hospitalization between control and experimental group | 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. | 7-10 days after enrollment in the study and 4-6 weeks after enrollment in the study |
| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| D000377 | Agnosia |
| D000098644 | Vaso-Occlusive Crises |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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