Ketamine Infusion for Sickle Cell Pain Crisis

Ketamine

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.

Intervention / Treatment

  • Ketamine (DRUG)
    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.
  • Pain management (OTHER)

Condition or Disease

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

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Withdrawn
    Study results: No Results Available
    Age: 18 Years to 70 Years
    Enrollment: 0 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    Clinical Trial Dates

    Start date: Jan 01, 2022 ESTIMATED
    Primary Completion: Nov 01, 2022 ESTIMATED
    Completion Date: Nov 01, 2022 ESTIMATED
    Study First Posted: Jul 02, 2019 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Dec 29, 2021

    Sponsors / Collaborators

    Lead Sponsor: Duke University
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    Durham, North Carolina, USA

    Participant Groups

    • 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.

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 70
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes
    • Percentage reduction in grand mean opioid consumption from 0 to 72 hours baseline, 72 hours
    Secondary Outcomes

    • 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

    More Details

    NCT Number: NCT04005209
    Other IDs: Pro00100887
    Study URL: https://clinicaltrials.gov/study/NCT04005209
    Last updated: Sep 29, 2023