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

NCT07369024 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 2024-33412-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sickle Cell Disease; Vaso-Occlusive Pain Episode in Sickle Cell Disease; Ketamine Infusion; Pain Management; Vaso-Occlusive Crises

Keywords

Sickle Cell Disease; Vaso-Occlusive Pain Episode; Sub-Dissociative Ketamine; Pediatric Pain Management

Outcome Measures

Primary Outcomes (1)

• Total Opioid Medications Required for Analgesia

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

  Up to 3 days

Secondary Outcomes (4)

• Pain Score

  30 minutes and 60 minutes after administration of placebo vs ketamine infusion

• ED Length of Stay

  Up to 3 days

• Rate of Hospitalization

  Up to 1 month

• Quality of Life (Pediatric Quality of Life)

  7-10 days after enrollment in the study and 4-6 weeks after enrollment in the study

Study Arms (2)

Sub-dissociative Ketamine

EXPERIMENTAL

Participants receiving 0.25 mg/kg infusion of ketamine

Drug: Sub-dissociative Ketamine Infusion

Normal Saline

PLACEBO COMPARATOR

Participants receiving 100 milliliters of normal saline

Drug: Normal Saline Placebo Infusion

Interventions

Sub-dissociative Ketamine Infusion DRUG

0.25 mg/kg of IV ketamine within a 20-minute infusion of 100 milliliters of normal saline (NS)

Sub-dissociative Ketamine

Normal Saline Placebo Infusion DRUG

20-minute infusion of 100 milliliters of normal saline

Normal Saline

Eligibility Criteria

• Age: 5 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify 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
• 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.

You may not qualify 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
• 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.

Sponsors & Collaborators

• Mohsen Saidinejad: lead

Study Sites (1)

Harbor UCLA Medical Center

Torrance, California, 90509, United States

RECRUITING

MeSH Terms

Conditions

Anemia, Sickle Cell; Agnosia; Vaso-Occlusive Crises

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Cynthia Luo, MD

CONTACT

310-222-2345; cluo2@dhs.lacounty.gov

Mohsen Saidinejad, MD

CONTACT

moh@emedharbor.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: January 27, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)