Low Dose Bolus Ketamine For Use In Sickle Cell Pain Crisis

Part of paid clinical trials in Jackson, Mississippi.

Sponsor
University of Mississippi Medical Center
Study ID
NCT07682662
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Sickle Cell Disease (SCD)
  • Vaso-Occlusive Pain Episode in Sickle Cell Disease

Eligibility Criteria

Sex
ALL
Age
2 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Standardized Low-dose bolus IV Ketamine within 30 minutes of arrival and every 1 hour as needed for max of 3 doses. — DRUG
    This dosing is based off of Ideal body weight of each patient and dosed at 0.3 mg/kg/dose.
  • Standard Care (in control arm) — OTHER
    Standard Care in Historical Control Group

Study Details

The goal of this study is to learn if Ketamine works more efficiently, as compared to Opioids, for Sickle Cell Pain The main questions it aims to answer are: Does Ketamine lower the number of times participants need to be admitted for continued pain control during a Sickle Cell Pain Crisis. Does Ketamine decrease the amount of time it takes to reach adequate pain control/pain score improvement, as compared to Opioids. Patients could have too low or too high blood pressure or sleepiness. Researchers will compare Ketamine to Opioids (Morphine or Dilaudid) to see if Ketamine works to treat pain enough that you do not need to be admitted to the hospital. Participants will: On arrival to the Children's ER for Sickle Cell Pain crisis will get Ketamine, instead of Morphine or Dilaudid, along with the typical Tylenol, Toradol, Lidocaine patch for pain control while in the ER. During this time we will follow your reported pain scale (0-10) to monitor your pain response to the Ketamine, as well as follow rate of hospital admission.

Key Dates

Start date
Aug 1, 2026
Status verified
Jun 2026
Primary completion
Aug 31, 2029
Completion
Oct 1, 2029

Study Design

Enrollment
400 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Any patient with confirmed Sickle Cell Disease in pain crisis.
    This group will be any patient, aged 2 years until 21 years with confirmed sickle cell disease who presents to the Pediatric Emergency Department with Pain will receive multimodal pain control using Acetaminophen, Toradol, lidocaine patch, and heat packs, as well as IV Ketamine in place of Opioids.
  • Other: Retrospective Historical Control Group
    Retrospective Historical Control Group

Primary Outcome Measure

Hospital admission rates after using a Ketamine first pathway as compared to after the use of Opioids. [ Time Frame: From time of patient enrollment and IRB approval for 36 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Mississippi Medical Center, Pediatric Emergency DepartmentJacksonMississippi39216
Cynthia Karlson, Ph.D.
[email protected]
601-984-2723
Elizabeth Adeyemi, MD (SUB_INVESTIGATOR)
Laci M Edwards, MD (SUB_INVESTIGATOR)

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By research site
University of Mississippi Medical Center, Pediatric Emergency Department· Jackson, MS

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