NCT07369024RecruitingPhase 2
Sub-dissociative Dose Ketamine in Treatment of Vaso-occlusive Pain Event in Children and Young Adults
Sub-dissociative Dose Ketamine in Treatment of Vaso-occlusive Pain Event in Children and Young Adults: A Randomized Control Trial
Source: ClinicalTrials.gov · Last updated 2 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 23 Jan 2026
- Start date
- 10 Sept 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Mohsen Saidinejad
- Diseases
- Sickle cell disease
- NCT number
- NCT07369024
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 120
- From 10 Sept 2026 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of prior adverse reaction to ketamine
- 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.
Other illness
- 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
Lab values
- Elevated liver enzymes (alkaline phosphatase, ALT, AST, bilirubin) as sign of hepatic disfunction if the laboratory results are available prior to study participation
Other
- 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
- Patients with evidence of increased intracranial pressure
- Patients with elevated intraocular pressure
- 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.
Who the study is looking for
- 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.
Age in the registry: 5 years to 20 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Harbor-UCLA Medical Center Coordinator of this site? Confirm its status | Torrance | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.