Ketamine Infusion for Sickle Cell Pain Crisis

Study Overview
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Brief Summary
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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.

Official Title
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Early Low-dose Ketamine Infusion Versus Usual Care for Sickle Cell Pain Crisis: a Randomized, Prospective Study.

Conditions
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Anemia; Sickle-Cell, With Crisis, Acute Pain

Intervention / Treatment
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* Drug: Ketamine
* Other: Pain management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a pre-existing/known diagnosis of sickle cell disease, prior to the current presentation Admitted to Duke University Hospital with a clinical diagnosis of sickle cell crisis Are at least 18 years old at time of admission Have been admitted to any hospital for sickle cell pain crisis at least twice in the last year Have documented severe pain at time of admission, requiring intravenous opiates Must be able to speak English Exclusion Criteria: Are greater than 70 years old at time of admission Carry a diagnosis of cirrhosis, elevated intracranial pressure, elevated intraocular pressure, active coronary artery disease, and psychiatric disorders with history of psychosis Are pregnant or breastfeeding Are concomitantly admitted for another medical or surgical problem in addition to sickle cell pain crisis Have been admitted to any hospital for a sickle cell pain crisis greater than 10 times in the last year Were admitted to any hospital for sickle cell pain crisis within the last 30 days Are able to fully and properly consent for their own medical care, with no restrictions or limitations

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pain management without ketamine infusion<br>Pain management without ketamine infusion. No other restrictions on pain management or medications. | Other: Pain management<br>* Pain management<br>|
| Experimental: Pain management with ketamine infusion<br>Pain management that includes a ketamine infusion. No other restrictions on pain management or medications. | Drug: Ketamine<br>* 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.<br>Other: Pain management<br>* Pain management<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage reduction in grand mean opioid consumption from 0 to 72 hours |  | baseline, 72 hours | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | Upon discharge from the hospital (an average of 1 week) | 
| 30-day hospital readmission rate |  | 30 days from discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ketamine, Intravenous Infusions, Anemia; Sickle-Cell, with Crisis, Acute Pain