Clinical trial NCT04005209: Ketamine Infusion for Sickle Cell Pain Crisis
Official title: Early Low-dose Ketamine Infusion Versus Usual Care for Sickle Cell Pain Crisis: a Randomized, Prospective Study.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Anemia; Sickle-Cell, With Crisis
Acute Pain
Keywords: Ketamine
Intravenous Infusions
Anemia; Sickle-Cell, with Crisis
Acute Pain
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2019-07-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage reduction in grand mean opioid consumption from 0 to 72 hours
timeFrame: baseline, 72 hours
Secondary outcomes:
measure: Percentage reduction in grand mean pain score using the 11-point visual analog scale
timeFrame: baseline, 72 hours
measure: Time from inpatient admission to readiness for discharge
timeFrame: Upon discharge from the hospital (an average of 1 week)
measure: 30-day hospital readmission rate
timeFrame: 30 days from discharge
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Hospital
state: North Carolina
Study officials:
References: