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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Mississippi Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 26, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings