Ketamine Infusion for Sickle Cell Pain Crisis

Sponsor

Duke University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04005209

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anemia; Sickle-Cell, With Crisis Acute Pain	Drug: Ketamine Other: Pain management	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Pain management without ketamine infusion Pain management without ketamine infusion. No other restrictions on pain management or medications.	Other: Pain management Pain management
Experimental: Pain management with ketamine infusion Pain management that includes a ketamine infusion. No other restrictions on pain management or medications.	Drug: Ketamine 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. Other: Pain management Pain management

Arm

Intervention/Treatment

Active Comparator: Pain management without ketamine infusion

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

Other: Pain management

Pain management

Experimental: Pain management with ketamine infusion

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

Drug: Ketamine

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.

Other: Pain management

Pain management

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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 Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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