NCT07369024 · Mohsen Saidinejad
Sub-dissociative Dose Ketamine in Treatment of Vaso-occlusive Pain Event in Children and Young Adults
What this study 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.
View original scientific description
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.
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
Primary outcome measures
Total Opioid Medications Required for Analgesia
Time frame: Up to 3 days
Cumulative morphine-mg equivalent per kilogram (MME/kg) of opioid medication needed to achieve a pain score of ≤ 5
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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.
Where
- Torrance, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 9, 2026 · Source of record for eligibility and locations