Ketamine Infusion for Sickle Cell Pain Crisis

NCT04005209 — Phase 4, Withdrawn, Duke University

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

Registry	NCT04005209
Status	Withdrawn - Decided not to open study
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: none, treatment
Sponsor	Duke University (Other)
Conditions	Anemia; Sickle-Cell, With Crisis, Acute Pain
Interventions	Ketamine, Pain management (Drug, other)
Dates	start 2022-01-01 (estimated), primary completion 2022-11-01 (estimated), completion 2022-11-01 (estimated), first posted 2019-07-02, last updated 2022-01-14
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Pain management without ketamine infusion	Active comparator	Other: Pain management	Pain management without ketamine infusion. No other restrictions on pain management or medications.
Pain management with ketamine infusion	Experimental	Drug: Ketamine; Other: Pain management	Pain management that includes a ketamine infusion. No other restrictions on pain management or medications.

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.
Pain management (Other): Pain management

+Outcome measures

Primary outcomes

Percentage reduction in grand mean opioid consumption from 0 to 72 hours [baseline, 72 hours]

Secondary outcomes

Percentage reduction in grand mean pain score using the 11-point visual analog scale [baseline, 72 hours]: Using standard 11-point visual analog pain scale, ranging from 0 = no pain to 10 = worst pain imaginable.
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]

+Eligibility

Sex: All, ages: 18 Years to 70 Years

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

+Locations (1)

Facility	City	Country	Status
Duke Hospital	Durham, North Carolina	United States