Ketamine Infusion for Sickle Cell Pain Crisis

Duke University

Status and phase: Withdrawn; Phase 4

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

Treatments: Other: Pain management; Drug: Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT04005209

Pro00100887

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Pain management without ketamine infusion

Active Comparator group

Description:

Pain management without ketamine infusion. No other restrictions on pain management or medications.

Treatment:

Other: Pain management

Pain management with ketamine infusion

Experimental group

Description:

Pain management that includes a ketamine infusion. No other restrictions on pain management or medications.

Treatment:

Drug: Ketamine

Other: Pain management