Ketamine for Sickle Cell Pain in Children and Young Adults

This study is looking at whether a low dose of ketamine, a medication often used for pain, can help children and young adults (ages 5-20) with sickle cell disease who are experiencing a pain crisis (vaso-occlusive pain event). Participants will receive either a low dose of intravenous (IV) ketamine along with their usual pain medication, or a placebo (normal saline) along with their usual pain medication. The main goal is to see if ketamine reduces the amount of opioid pain medication needed over three days. You can join if you have sickle cell disease and are currently having a pain crisis that requires IV pain medication. The study is currently unclear on its status and plans to enroll 120 participants.

Study design
This interventional study plans to enroll 120 participants. It compares two groups: one receiving ketamine and the other receiving a placebo (normal saline).
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 3 days to measure the total opioid medications required for pain relief.

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NCT07369024

Sub-dissociative Dose Ketamine in Treatment of Vaso-occlusive Pain Event in Children and Young Adults

Recruiting
PHASE2Ages 5–20InterventionalTreatment
Mohsen Saidinejad
~120 participants
Updated 2026-03-09 on ClinicalTrials.gov
What's tested:Sub-dissociative Ketamine InfusionNormal Saline Placebo Infusion

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Total Opioid Medications Required for Analgesia
Measured over Up to 3 days
Sickle Cell Disease
Vaso-Occlusive Pain Episode in Sickle Cell Disease
Ketamine Infusion
Pain Management
Vaso-Occlusive Crises
1 sites across 1 states
California1

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Eligibility criteria

Inclusion

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

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.
  • Total Opioid Medications Required for AnalgesiaUp to 3 days

    Cumulative morphine-mg equivalent per kilogram (MME/kg) of opioid medication needed to achieve a pain score of ≤ 5