Low-dose ketamine for sickle cell vaso-occlusive pain in children and young adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2, placebo-controlled interventional trial compares sub-dissociative ketamine plus standard-of-care IV opioid analgesia to standard-of-care with a saline placebo infusion in patients aged 5–20 with sickle cell disease presenting with vaso-occlusive pain. Participants receive an initial opioid dose before enrollment and are randomized to receive either a low-dose ketamine infusion or a matching saline infusion alongside usual pain management. The study will track pain scores, opioid requirements, and safety outcomes during the acute pain episode. All procedures are performed at a single center with monitoring for adverse reactions to ketamine.

Why it matters

Who can join: the full rules

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 it's running

• Harbor UCLA Medical Center
  Torrance, California, United States Recruiting

Study contacts

• Study coordinator: Cynthia Luo, MD
• Email: cluo2@dhs.lacounty.gov
• Phone: 310-222-2345

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Morphine removal and kidney filtering in adults with sickle cell crises in intensive care

  This project will test how quickly morphine is cleared from the body in adults with sickle cell disease admitted to intensive care for vaso-occlusive crisis or acute chest syndrome, and whether faster kidney filtering leads to lower morphine levels.

  Recruiting University Hospital, Tours · Tours, France and 5 other locations · NCT07246265

• Regional anesthesia to reduce inflammation during vaso‑occlusive crises in sickle cell disease

  This project will test whether giving regional (loco‑regional) anesthesia to adults hospitalized for sickle cell vaso‑occlusive crises reduces inflammatory markers and speeds recovery compared with usual care.

  Recruiting Centre Hospitalier Universitaire de la Guadeloupe · Pointe-à-Pitre · NCT07001189

• Using virtual reality to help manage pain in sickle cell disease patients

  This study is testing if using virtual reality can help adults with sickle cell disease feel less pain during painful episodes.

  Recruiting University of Maryland, Baltimore · Baltimore, Maryland · NCT06184126

• Dexmedetomidine as add-on for refractory cancer pain in palliative care

  This study tests whether adding dexmedetomidine helps improve pain control for adults with cancer in palliative care whose pain remains high despite opioids.

  Recruiting St. Olavs Hospital · Drammen and 3 other locations · NCT07885475

• Two Ways to Help Pain After Breast Surgery: Education-Based Analgesia vs Standard Care

  This trial tests whether teaching patients about pain management and using a multimodal pain plan improves pain control and recovery after breast surgery compared with standard care.

  Recruiting University General Hospital of Heraklion · Heraklion, Crete · NCT07880223

• Virtual Reality Therapy to Improve Arthroplasty Outcomes

  This pilot test checks whether using virtual reality during the perioperative period helps knee or hip replacement patients feel better about their care and recover more easily.

  Recruiting NHS Highland Research, Development and Innovation Organisation · Inverness, Highlands · NCT07872670

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.