Back to resultsKetamine Infusion for Sickle Cell Pain Crisis
Primary Purpose
Anemia; Sickle-Cell, With Crisis, Acute Pain
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ketamine
Pain management
Sponsored by
About this trial
This is an interventional treatment trial for Anemia; Sickle-Cell, With Crisis focused on measuring Ketamine, Intravenous Infusions, Anemia; Sickle-Cell, with Crisis, Acute Pain
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
Sites / Locations
- Duke Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Pain management without ketamine infusion
Pain management with ketamine infusion
Arm Description
Pain management without ketamine infusion. No other restrictions on pain management or medications.
Pain management that includes a ketamine infusion. No other restrictions on pain management or medications.
Outcomes
Primary Outcome Measures
Percentage reduction in grand mean opioid consumption from 0 to 72 hours
Secondary Outcome Measures
Percentage reduction in grand mean pain score using the 11-point visual analog scale
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
30-day hospital readmission rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04005209
Brief Title
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
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Decided not to open study
Study Start Date
January 2022 (Anticipated)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
November 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia; Sickle-Cell, With Crisis, Acute Pain
Keywords
Ketamine, Intravenous Infusions, Anemia; Sickle-Cell, with Crisis, Acute Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pain management without ketamine infusion
Arm Type
Active Comparator
Arm Description
Pain management without ketamine infusion. No other restrictions on pain management or medications.
Arm Title
Pain management with ketamine infusion
Arm Type
Experimental
Arm Description
Pain management that includes a ketamine infusion. No other restrictions on pain management or medications.
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention 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.
Intervention Type
Other
Intervention Name(s)
Pain management
Intervention Description
Pain management
Primary Outcome Measure Information:
Title
Percentage reduction in grand mean opioid consumption from 0 to 72 hours
Time Frame
baseline, 72 hours
Secondary Outcome Measure Information:
Title
Percentage reduction in grand mean pain score using the 11-point visual analog scale
Description
Using standard 11-point visual analog pain scale, ranging from 0 = no pain to 10 = worst pain imaginable.
Time Frame
baseline, 72 hours
Title
Time from inpatient admission to readiness for discharge
Time Frame
Upon discharge from the hospital (an average of 1 week)
Title
30-day hospital readmission rate
Time Frame
30 days from discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Duke Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Ketamine Infusion for Sickle Cell Pain Crisis
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