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

Part of paid clinical trials in Torrance, California.

Sponsor
Mohsen Saidinejad
Study ID
NCT07369024
Phase
PHASE2
Status
Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
5 Years - 20 Years
Healthy Volunteers
Not accepted

Interventions

  • Sub-dissociative Ketamine Infusion — DRUG
    0.25 mg/kg of IV ketamine within a 20-minute infusion of 100 milliliters of normal saline (NS)
  • Normal Saline Placebo Infusion — DRUG
    20-minute infusion of 100 milliliters of normal saline

Study Details

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.

Key Dates

Start date
Apr 1, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Sub-dissociative Ketamine
    Participants receiving 0.25 mg/kg infusion of ketamine
  • Placebo Comparator: Normal Saline
    Participants receiving 100 milliliters of normal saline

Primary Outcome Measure

Total Opioid Medications Required for Analgesia [ Time Frame: Up to 3 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Harbor UCLA Medical CenterTorranceCalifornia90509
Cynthia Luo, MD
310-222-2345
Mohsen Saidinejad, MD (PRINCIPAL_INVESTIGATOR)

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