Sub-dissociative Dose Ketamine in Treatment of Vaso-occlusive Pain Event in Children and Young Adults
NCT07369024 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2026-03-09
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.
Conditions
- Sickle Cell Disease
- Vaso-Occlusive Pain Episode in Sickle Cell Disease
- Ketamine Infusion
- Pain Management
- Vaso-Occlusive Crises
Interventions
- DRUG
-
Sub-dissociative Ketamine Infusion
0.25 mg/kg of IV ketamine within a 20-minute infusion of 100 milliliters of normal saline (NS)
- DRUG
-
Normal Saline Placebo Infusion
20-minute infusion of 100 milliliters of normal saline
Sponsors & Collaborators
-
Mohsen Saidinejad
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 5 Years
- Max Age
- 20 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-01
- Primary Completion
- 2027-12-31
- Completion
- 2028-04-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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