Not Yet RecruitingPhase 4ketamine

Low Dose Bolus Ketamine For Use In Sickle Cell Pain Crisis

Sponsored by University of Mississippi Medical Center

NCT ID
NCT07682662
Target Enrollment
400 participants
Start Date
2026-08-01
Est. Completion
2029-10-01

About This Study

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.

Conditions Studied

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

Interventions

  • Standardized Low-dose bolus IV Ketamine within 30 minutes of arrival and every 1 hour as needed for max of 3 doses.
  • Standard Care (in control arm)

Eligibility

Age:2 Years - 21 Years
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria:

* Confirmed Sickle Cell Disease (any genotype), Presenting to the Emergency Department with Vaso-occlusive crisis/pain crisis, Consent obtained

Exclusion Criteria:

* Ketamine allergy, Severe agitation/psychosis, Pregnancy, Hemodynamic instability (as judged by physician), Increased intracranial pressure, Severe hepatic impairment, Ketamine use within the previous 24 hours, Presentation for non-VOC-related pain (i.e. fever, acute chest syndrome, stroke, traumatic injuries etc).

Study Locations (1)

University of Mississippi Medical Center, Pediatric Emergency Department
Jackson, Mississippi, United States

Interested in this trial?

Contact the study team to learn more about eligibility and enrollment.

Cynthia Karlson, Ph.D.
CONTACT
601-984-2723ckarlson@umc.edu
View on ClinicalTrials.gov
Data Source
ClinicalTrials.gov

Last updated from source