Ketamine Infusion for Sickle Cell Pain Crisis

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

Sponsors

Lead Sponsor: Duke University

Source Duke University
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.

Overall Status Not yet recruiting
Start Date September 1, 2020
Completion Date January 1, 2021
Primary Completion Date September 1, 2020
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Percentage reduction in grand mean opioid consumption from 0 to 72 hours baseline, 72 hours
Secondary Outcome
Measure Time Frame
Percentage reduction in grand mean pain score using the 11-point visual analog scale 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
Enrollment 48
Condition
Intervention

Intervention Type: Drug

Intervention Name: Ketamine

Description: 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.

Arm Group Label: Pain management with ketamine infusion

Intervention Type: Other

Intervention Name: Pain management

Description: Pain management

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Healthy Volunteers: No

Overall Contact

Last Name: Neil Ray, MD

Phone: 9196811924

Email: [email protected]

Location
Facility: Contact: Contact Backup: Investigator: Duke Hospital David W Creighton, MD [email protected] David W Creighton, MD Sub-Investigator Nirmish Shah, MD Sub-Investigator Neil Ray, MD Principal Investigator Milly Rambhia, MD Sub-Investigator Elizabeth Gauthier, MD Sub-Investigator Christian Horazeck, MD Sub-Investigator
Location Countries

United States

Verification Date

April 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Pain management without ketamine infusion

Type: Active Comparator

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

Label: Pain management with ketamine infusion

Type: Experimental

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

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov