Actively Recruiting

Phase 2
Age: 5Years - 20Years
All Genders
NCT07369024

Sub-dissociative Dose Ketamine in Treatment of Vaso-occlusive Pain Event in Children and Young Adults

Led by Mohsen Saidinejad · Updated on 2026-03-09

120

Participants Needed

1

Research Sites

108 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this research is to see if ketamine is effective and safe in treating children and young adults with sickle cell disease experiencing sickle cell related pain. In this study, we will compare the outcomes (such as pain scores) in persons who receive standard of care pain medicine (an opioid such as morphine) plus a low dose (amount) of ketamine to those who receive only standard of care pain medicine.

CONDITIONS

Official Title

Sub-dissociative Dose Ketamine in Treatment of Vaso-occlusive Pain Event in Children and Young Adults

Who Can Participate

Age: 5Years - 20Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Between the ages 5-20 years
  • Diagnosed sickle cell disease including HbSS, HbSC, HbSBetaThal Plus or Zero
  • Presenting with vaso-occlusive episode pain requiring intravenous pain medication
  • First dose of analgesic medication given before study approach
  • Primary language is English or Spanish
  • Adult or parent/legal guardian able and willing to provide informed consent; assent provided by ages 7 to 17 when possible
Not Eligible

You will not qualify if you...

  • Sickle cell trait only
  • Primary language other than English or Spanish
  • Pain caused by reasons other than vaso-occlusive episode
  • Not requiring intravenous pain treatment
  • No analgesic given before study approach for any reason
  • Oxygen saturation less than 90% on room air
  • History of adverse reaction to ketamine
  • Active or uncontrolled hypertension (systolic over 140 mmHg or diastolic over 90 mmHg)
  • Significant or uncontrolled cardiovascular, liver, kidney, or thyroid disease
  • Evidence of increased intracranial or elevated intraocular pressure
  • Acute mania or bipolar disorder with mania, hallucinations, or paranoia
  • Pregnant or potentially pregnant patients
  • Elevated liver enzymes indicating liver dysfunction
  • Patients appearing intoxicated
  • Patients who are wards of the state or prisoners
  • Patients not competent to provide consent or assent

AI-Screening

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Trial Site Locations

Total: 1 location

1

Harbor UCLA Medical Center

Torrance, California, United States, 90509

Actively Recruiting

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Research Team

C

Cynthia Luo, MD

CONTACT

M

Mohsen Saidinejad, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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