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The purpose of this study is to prospectively study the efficacy of low dose ketamine infusions in treating patients who are admitted to the hospital with a sickle cell pain crisis. Participants will be prospectively randomized in unblinded fashion in the first 12 to 24 hours of an inpatient admission for sickle cell pain crisis to receive pain management without ketamine infusion (Group A) versus pain management that includes low-dose ketamine infusion starting at 0.2mg/kg/h (Group B). The effect of this intervention on various pain management and healthcare utilization outcome measures will be recorded and analyzed to determine whether or not there is a measurable benefit of using ketamine infusions in this patient population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pain management without ketamine infusion | Active Comparator | Pain management without ketamine infusion. No other restrictions on pain management or medications. |
|
| Pain management with ketamine infusion | Experimental | Pain management that includes a ketamine infusion. No other restrictions on pain management or medications. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | The experimental group will receive a ketamine intravenous infusion, initiated at 0.2 mg/kg/hr within the first 12 to 24 hours on an inpatient admission for sickle cell pain crisis, and titrated per hospital policy by the inpatient pain service. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage reduction in grand mean opioid consumption from 0 to 72 hours | baseline, 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage reduction in grand mean pain score using the 11-point visual analog scale | Using standard 11-point visual analog pain scale, ranging from 0 = no pain to 10 = worst pain imaginable. | baseline, 72 hours |
| Time from inpatient admission to readiness for discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Hospital | Durham | North Carolina | 27710 | United States |
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| ID | Term |
|---|---|
| D000098644 | Vaso-Occlusive Crises |
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| D059408 | Pain Management |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| Pain management | Other | Pain management |
|
| Upon discharge from the hospital (an average of 1 week) |
| 30-day hospital readmission rate | 30 days from discharge |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D013812 | Therapeutics |
| D019468 | Disease Management |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |