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 — DRUG0.25 mg/kg of IV ketamine within a 20-minute infusion of 100 milliliters of normal saline (NS)
- Normal Saline Placebo Infusion — DRUG20-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 KetamineParticipants receiving 0.25 mg/kg infusion of ketamine
- Placebo Comparator: Normal SalineParticipants receiving 100 milliliters of normal saline
Primary Outcome Measure
Total Opioid Medications Required for Analgesia [ Time Frame: Up to 3 days ]
Central Contacts
- Cynthia Luo, MD310-222-2345
- Mohsen Saidinejad, MD
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Harbor UCLA Medical Center | Torrance | California | 90509 | Mohsen Saidinejad, MD (PRINCIPAL_INVESTIGATOR) |
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