Ketamine Infusion for Sickle Cell Pain Crisis

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 1, 2020

Interventions

  • 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

Arms, Groups and Cohorts

  • Active Comparator: Pain management without ketamine infusion
    • Pain management without ketamine infusion. No other restrictions on pain management or medications.
  • Experimental: Pain management with ketamine infusion
    • Pain management that includes a ketamine infusion. No other restrictions on pain management or medications.

Clinical Trial Outcome Measures

Primary Measures

  • Percentage reduction in grand mean opioid consumption from 0 to 72 hours
    • Time Frame: baseline, 72 hours

Secondary Measures

  • Percentage reduction in grand mean pain score using the 11-point visual analog scale
    • Time Frame: 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
    • Time Frame: Upon discharge from the hospital (an average of 1 week)
  • 30-day hospital readmission rate
    • Time Frame: 30 days from discharge

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Duke University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Neil Ray, MD, 9196811924, neil.d.ray@duke.edu

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