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Low Dose Bolus Ketamine For Use In Sickle Cell Pain Crisis

NCT07682662 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2026-07-06

No results posted yet for this study

Summary

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

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

Interventions

DRUG

Standardized Low-dose bolus IV Ketamine within 30 minutes of arrival and every 1 hour as needed for max of 3 doses.

This dosing is based off of Ideal body weight of each patient and dosed at 0.3 mg/kg/dose.

OTHER

Standard Care (in control arm)

Standard Care in Historical Control Group

Sponsors & Collaborators

  • University of Mississippi Medical Center

    lead OTHER

Principal Investigators

  • John N Freeman, MD · University of Mississippi Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2029-08-31
Completion
2029-10-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07682662 on ClinicalTrials.gov