Ketamine Infusion for Sickle Cell Pain Crisis

• ClinicalTrials.gov Identifier: NCT04005209
• Recruitment Status: Not yet recruiting
• First Posted: July 2, 2019
• Last Update Posted: September 25, 2020
• Sponsor: Duke University
• Information provided by (Responsible Party): Duke University

Tracking Information

• First Submitted Date: June 28, 2019
• First Posted Date: July 2, 2019
• Last Update Posted Date: September 25, 2020
• Estimated Study Start Date: January 2021
• Estimated Primary Completion Date: July 2021 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 1, 2019): Percentage reduction in grand mean opioid consumption from 0 to 72 hours [ Time Frame: baseline, 72 hours ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 1, 2019)

• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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.
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

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

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

Study Arms

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

  • Drug: Ketamine
  • Other: Pain management

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: July 1, 2019): 48
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 2021
• Estimated Primary Completion Date: July 2021 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Neil Ray, MD; 9196811924; neil.d.ray@duke.edu

Contact: David W Creighton, MD; david.creighton@duke.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04005209
• Other Study ID Numbers: Pro00100887
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Duke University
• Study Sponsor: Duke University
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Duke University
• Verification Date: September 2020