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New treatment option for Sickle Cell Disease
Official title Sub-dissociative Dose Ketamine in Treatment of Vaso-occlusive Pain Event in Children and Young Adults
ClinicalTrials.gov ID: NCT07369024
What this study is testing
What is Sub-dissociative Ketamine Infusion?
Sub-dissociative Ketamine Infusion is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for sickle cell disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 20
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Torrance, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 5 years to 20 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Torrance, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.