Low-dose ketamine for sickle cell vaso-occlusive pain 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

This trial will test whether adding a low (sub-dissociative) dose ketamine infusion to usual IV opioid pain medicine helps children and young adults (ages 5–20) with sickle cell disease have better pain relief and remain safe during a vaso-occlusive episode.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 5 Years to 20 Years
• Sex: All
• Sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center (Academic / other)
• Locations: 1 site (Torrance, California)
• Trial ID: NCT07369024 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Children and young adults aged 5–20 with diagnosed sickle cell disease (HbSS, HbSC, HbSβ thalassemia) who present with a vaso-occlusive pain episode requiring IV analgesia and who speak English or Spanish are eligible candidates.

Not a fit: Patients with only sickle cell trait, pain from causes other than a VOE, oxygen saturation under 90% on room air, a history of adverse reaction to ketamine, a history of hypertension, those not requiring IV pain treatment, or those who cannot consent in English or Spanish are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, adding low-dose ketamine could provide faster or stronger pain relief and reduce the amount of opioid medication needed during vaso-occlusive episodes.

How similar studies have performed: Prior emergency-department and small sickle cell studies using sub-dissociative ketamine for acute pain have often reported reduced opioid use and improved pain scores, but the evidence is limited and somewhat mixed.

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.

Where this trial is running

Torrance, California

• Harbor UCLA Medical Center — Torrance, California, United States (Recruiting)

Study contacts

• Study coordinator: Cynthia Luo, MD

Conditions Sickle Cell Disease; Vaso-Occlusive Pain Episode in Sickle Cell Disease; Ketamine Infusion; Pain Management; Vaso-Occlusive Crises; Vaso-Occlusive Pain Episode; Sub-Dissociative Ketamine; Pediatric Pain Management