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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 5 Years to 20 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether adding low-dose ketamine to usual pain medicine, such as morphine, is safe and helps reduce sickle cell pain. It is for children and young adults ages 5–20 who need pain medicine through a vein.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are 5–20 years old.
- You have sickle cell disease: HbSS, HbSC, or HbS beta thalassemia plus or zero.
- You have a sickle cell pain crisis caused by blocked blood flow and need IV pain medicine (given through a vein).
- You receive your first dose of pain medicine before being asked to join.
- Your main language is English or Spanish.
- You, if an adult, or your parent or legal guardian can and will give permission. Children ages 7–17 must also agree when able to understand.
Who can't join
- You have only sickle cell trait, not the disease; your pain is not from a sickle cell pain crisis; or you do not need IV pain treatment.
- Your main language is not English or Spanish, or you have not received pain medicine before being asked to join.
- Your blood oxygen level is below 90% while breathing room air, or you have had a bad reaction to ketamine.
- You have uncontrolled high blood pressure above the study's 140/90 limits, or serious or uncontrolled heart, blood vessel, liver, kidney, or thyroid disease.
- You have high pressure inside your skull or eyes, or available blood tests show signs of liver problems.
- You have current mania (extremely high energy or mood), bipolar disorder with past mania, or a mental health condition that has caused hallucinations (sensing things that are not there) or paranoia (strong fears that others want to harm you).
- You are pregnant or might be pregnant, or you appear to be under the influence of alcohol or drugs. Anyone who could become pregnant will have a pregnancy test before joining.
- You are in state custody or prison, or you cannot give the required permission or agreement to join.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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.
Study sites (1)
CA
- Harbor UCLA Medical Center · Torrance, CA 90509Cynthia Luo, MD · Study contact · 310-222-2345 · cluo2@dhs.lacounty.govMohsen Saidinejad, MD · Principal investigatorMore trials in Torrance