Low Dose Bolus Ketamine For Use In Sickle Cell Pain Crisis

June 26, 2026 updated by: Cynthia Karlson, University of Mississippi Medical Center

Evaluation of a Standardized Low-Dose Bolus Ketamine Pathway for Management of Pediatric Sickle Cell Patients Presenting to the Emergency Department With Pain

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

In this study, we will be using Ketamine for pain control during a Sickle Cell Disease pain crisis, along with our current adjuncts (Tylenol, Toradol, Lidocaine patch, or heat packs), in hopes to lower the rate of admission to the hospital for continued pain control.

When presenting to the ER for pain crisis the first dose of Ketamine should be given within 30 minutes of arrival to the ER. Prior to giving Ketamine, vitals and current pain scale will be recorded in the chart. The vitals and pain scale will be rechecked every 30 minutes and documented in the chart. If a second or third dose is needed at the one-hour mark, then a second dose will be given. If after the second dose the patient does not report sufficient pain control then a third dose will be given and the patient will be admitted to the hospital.

The patient is free to opt out of the Ketamine pathway at any time and Opioids can be administered.

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Cynthia Karlson, Ph.D.
  • Phone Number: 601-984-2723
  • Email: ckarlson@umc.edu

Study Locations

  • United States
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center, Pediatric Emergency Department
        • Contact:
        • Sub-Investigator:
          • Elizabeth Adeyemi, MD
        • Sub-Investigator:
          • Laci M Edwards, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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: Retrospective Historical Control Group
Other: Standard Care (in control arm)
Standard Care in Historical Control Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
From time of patient enrollment and IRB approval for 36 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Emergency Department length of stay after using the Ketamine first pathway.
Time Frame: From time of patient enrollment and IRB approval until 36 months.
From time of patient enrollment and IRB approval until 36 months.
Pain score reduction in the acute setting after using a Ketamine first pathway as compared to Opioid first pathway.
Time Frame: From time of patient enrollment and IRB approval until 36 months.
From time of patient enrollment and IRB approval until 36 months.
Rate of repeat visits to the Emergency Department within 72 hours for pain after a Ketamine first pathway was followed.
Time Frame: From time of patient enrollment and IRB approval until 36 months.
From time of patient enrollment and IRB approval until 36 months.
Inpatient length of stay (in number of days) for to reach adequate length of stay.
Time Frame: From time of patient enrollment and IRB approval until 36 months
From time of patient enrollment and IRB approval until 36 months
Adverse events experienced after using a Ketamine first pathway
Time Frame: From time of patient enrollment and IRB approval until 36 months.
From time of patient enrollment and IRB approval until 36 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Mississippi Medical Center

Investigators

  • Principal Investigator: John N Freeman, MD, University of Mississippi Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

August 31, 2029

Study Completion (Estimated)

October 1, 2029

Study Registration Dates

First Submitted

June 26, 2026

First Submitted That Met QC Criteria

June 26, 2026

First Posted (Actual)

July 6, 2026

Study Record Updates

Last Update Posted (Actual)

July 6, 2026

Last Update Submitted That Met QC Criteria

June 26, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMMC-IRB-2026-154

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Our data will remain on a secured REDCAP. De-identified data may be shared upon reasonable request.

Drug and device information, study documents

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.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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