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RecruitingNCT07369024Updated Sep 2, 2026

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

A Phase 2 interventional study of Sub-dissociative Ketamine Infusion and Normal Saline Placebo Infusion in Sickle Cell Disease, Vaso-Occlusive Pain Episode in Sickle Cell Disease and Ketamine Infusion, sponsored by Mohsen Saidinejad. Recruiting at 1 site in United States. Open to participants aged 5 Years to 20 Years. Per ClinicalTrials.gov, last updated 2026-09-02.

Sponsored by Mohsen Saidinejad · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
5 Years to 20 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Sickle Cell Disease
  • Vaso-Occlusive Pain Episode in Sickle Cell Disease
  • Ketamine Infusion
  • Pain Management
  • Vaso-Occlusive Crises

Keywords

  • Sickle Cell Disease
  • Vaso-Occlusive Pain Episode
  • Sub-Dissociative Ketamine
  • Pediatric Pain Management
03

In context

Anemia, Sickle Cell

1,103 studies on the registry are indexed under Anemia, Sickle Cell; 235 are open to participants now.

This study's planned enrollment of 120 is above the median of 40 across 750 interventional studies indexed under Anemia, Sickle Cell.

Browse Anemia, Sickle Cell studies →

Lead sponsor

This is the only study on the registry with Mohsen Saidinejad as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 20 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Between the ages 5-20 years
  • Diagnosed sickle cell disease. Homozygous (HbSS) or heterozygous (HbSC, HbSBetaThal Plus or Zero) will be included.
  • Presenting with VOE pain, requiring IV pain medication.
  • First dose of analgesic medication is given before patient approached for participation in the study.
  • Primary language is English or Spanish
  • Adult individual or parent/legal guardian is able and willing to provide informed consent. For individuals 7 to 17 years of age, assent must also be provided when cognitively possible.

Exclusion criteria

Exclusion Criteria:

  • Sickle cell trait only
  • Patients whose primary language is other than English or Spanish
  • Pain attributed to causes other than VOE
  • Not requiring IV for pain treatment
  • No analgesic (e.g. opiate) is given before approach for study participation due to any reason, including problem with IV access.
  • Oxygen saturation \< 90% on room air
  • History of prior adverse reaction to ketamine
  • History of hypertension - Patients with active/uncontrolled hypertension defined as systolic 140 mmHg over diastolic of 90 mmHg will be excluded from participation in the study. If hypertension is controlled and at the time of enrollment, systolic and diastolic thresholds of 140 mmHg and 90 mmHg respectively are not exceeded, patient may be included in the study
  • History of significant or uncontrolled cardiovascular disease, liver disease, kidney disease, and thyroid disease
  • Patients with evidence of increased intracranial pressure
  • Patients with elevated intraocular pressure
  • Patients with acute mania or history of bipolar disorder with manic episodes, history of hallucinations or paranoia secondary to previously diagnosed psychiatric condition
  • Pregnant or potentially pregnant patients per patient report. All patients of childbearing potential will undergo pregnancy testing prior to enrollment (as part of clinical care), and if positive, will be excluded.
  • Elevated liver enzymes (alkaline phosphatase, ALT, AST, bilirubin) as sign of hepatic disfunction if the laboratory results are available prior to study participation
  • Patients who appear intoxicated on any substance.
  • Patients who are wards of the state or prisoners as defined by DHS
  • Patients who are not deemed to be competent to provide consent or assent.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Sub-dissociative Ketamine

    Participants receiving 0.25 mg/kg infusion of ketamine

    Drug: Sub-dissociative Ketamine Infusion

  • Placebo comparator
    Normal Saline

    Participants receiving 100 milliliters of normal saline

    Drug: Normal Saline Placebo Infusion

Interventions

  • DrugSub-dissociative Ketamine Infusion

    0.25 mg/kg of IV ketamine within a 20-minute infusion of 100 milliliters of normal saline (NS)

  • DrugNormal Saline Placebo Infusion

    20-minute infusion of 100 milliliters of normal saline

06

What researchers measure

Primary outcomes

  1. Total Opioid Medications Required for Analgesia

    Cumulative morphine-mg equivalent per kilogram (MME/kg) of opioid medication needed to achieve a pain score of ≤ 5

    Time frame: Up to 3 days

Secondary outcomes

  1. Pain Score

    Pain score from 0-10, at 30 and 60 minutes after administration of NS/placebo (control group), versus sub-dissociative ketamine (experimental group)

    Time frame: 30 minutes and 60 minutes after administration of placebo vs ketamine infusion

  2. ED Length of Stay

    To compare ED length of stay between control vs experimental group

    Time frame: Up to 3 days

  3. Rate of Hospitalization

    To compare rate of hospitalization and length of hospitalization between control and experimental group

    Time frame: Up to 1 month

  4. Quality of Life (Pediatric Quality of Life)

    To compare overall quality of life between the two groups upon discharge from the ED or the hospital, using the Pediatric Quality of Life (PedsQL) questionnaire. The questionnaire has 43 points and is reverse scored and linearly transformed to a 0-100 scale (0=100, 1=75, 2=50, 3=25, 4=0), so that higher scores indicate better quality of life.

    Time frame: 7-10 days after enrollment in the study and 4-6 weeks after enrollment in the study

07

Study locations

1 of 1 sites recruiting
  • Harbor UCLA Medical Center
    Torrance, California 90509, United States
    • Cynthia Luo, MD · Contact · cluo2@dhs.lacounty.gov · 310-222-2345
    • Mohsen Saidinejad, MD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07369024
Lead sponsor
Mohsen Saidinejad
Responsible party
Mohsen Saidinejad (Principal Investigator, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center) — Sponsor-investigator
First posted
Jan 27, 2026
Start date
Sep 10, 2026 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Apr 30, 2028 (estimated)
Last update
Sep 2, 2026

Study contacts

Cynthia Luo, MD
Contact
cluo2@dhs.lacounty.gov
310-222-2345
Mohsen Saidinejad, MD
Contact
moh@emedharbor.edu

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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