Ketamine Infusion for Sickle Cell Pain Crisis

Acute Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04005209
• Other study ID #: Pro00100887
• Status: Withdrawn
• Phase: Phase 4
• Start date: January 2022
• Est. completion date: November 2022

Study information

• Verified date: December 2021
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Anemia, Sickle Cell
• Anemia; Sickle-Cell, With Crisis

Intervention

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

Locations

Country	Name	City	State
United States	Duke Hospital	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage reduction in grand mean opioid consumption from 0 to 72 hours		baseline, 72 hours
Secondary	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.	baseline, 72 hours
Secondary	Time from inpatient admission to readiness for discharge		Upon discharge from the hospital (an average of 1 week)
Secondary	30-day hospital readmission rate		30 days from discharge