Clinical TrialSingle-armChronic PainKetaminePlaceboNot yet recruiting

Low Dose Bolus Ketamine For Use In Sickle Cell Pain Crisis

This Phase IV, non-randomised, single-group interventional trial (n=400) will assess whether a standardised low-dose bolus ketamine pathway can improve pain management for children and young adults aged 2 to 21 years with confirmed sickle cell disease presenting to the emergency department with a vaso-occlusive pain episode. The study will compare ketamine-based acute pain treatment with historical opioid-based standard care, with the main aim of reducing hospital admission rates and improving the time to adequate pain control. Participants in the ketamine pathway will receive multimodal analgesia with acetaminophen, Toradol, lidocaine patch and heat packs, together with intravenous ketamine at 0.3 mg/kg/dose based on ideal body weight, given within 30 minutes of arrival and then every 1 hour as needed for a maximum of 3 doses. Pain scores and vital signs will be recorded before treatment and then every 30 minutes, and admission will follow if sufficient pain relief is not achieved after repeat dosing. A retrospective historical control group will represent standard care, and the study will also monitor safety concerns such as hypotension, hypertension and drowsiness.

Target Enrollment
400 participants
Study Type
Phase IV interventional
Design
Non-randomized

Detailed Description

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 Arms & Interventions

Any patient with confirmed Sickle Cell Disease in pain crisis.

experimental

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.

Interventions

  • Ketamine0.3 mg/kg
    via IVwithin 30 minutes of arrival and every 1 hour as needed3 doses total

Retrospective Historical Control Group

experimental

Retrospective Historical Control Group

Interventions

  • Placebo

    Unmatched intervention treated as placebo placeholder: Standard Care (in control arm)

Participants

Ages
221
Sexes
Male & Female

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 Protocol, Arms & Participants

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Study Details

  • Status
    Not yet recruiting
  • Phase
    Phase IV
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment400 participants
  • Timeline
    Start: 2026-08-01
    End: 2029-10-01
  • Compounds
  • Topic

Study Team

Sponsors & Collaborators

Locations

University of Mississippi Medical Center, Pediatric Emergency DepartmentJackson, Mississippi, United States

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