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NCT Number: NCT07682662

Low Dose Bolus Ketamine For Use In Sickle Cell Pain Crisis

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.

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Key information

Conditions

Vaso-Occlusive Pain Episode in Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Sickle Cell Disease (SCD)

Age range

2 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Mississippi Medical Center, Pediatric Emergency Department

Jackson, Mississippi, 39216, United States

Location contact

Cynthia Karlson, Ph.D.

CONTACT

[email protected]

601-984-2723

Elizabeth Adeyemi, MD

SUB_INVESTIGATOR

Laci M Edwards, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Emergency Department length of stay after using the Ketamine first pathway.

    Time frame: From time of patient enrollment and IRB approval until 36 months.

  2. 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.

  3. 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.

  4. 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

  5. Adverse events experienced after using a Ketamine first pathway

    Time frame: From time of patient enrollment and IRB approval until 36 months.

Study contacts

Contact information is provided by the study sponsor or research team.

Cynthia Karlson, Ph.D.

CONTACT

[email protected]

601-984-2723

Sponsors and collaborators

Lead sponsor

University of Mississippi Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jul 6, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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