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

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.

Study Overview

• Status: Recruiting
• Conditions: Sickle Cell Disease; Pain Management; Vaso-Occlusive Pain Episode in Sickle Cell Disease; Vaso-Occlusive Crises; Ketamine Infusion
• Intervention / Treatment: Drug: Sub-dissociative Ketamine Infusion; Drug: Normal Saline Placebo Infusion

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Cynthia Luo, MD; Phone Number: 310-222-2345; Email: cluo2@dhs.lacounty.gov
• Study Contact Backup: Name: Mohsen Saidinejad, MD; Email: moh@emedharbor.edu

Study Locations

• United States
  • California
    • Torrance, California, United States, 90509
      • Recruiting
      • Harbor UCLA Medical Center
      • Contact: Cynthia Luo, MD; Phone Number: 310-222-2345; Email: cluo2@dhs.lacounty.gov
      • Principal Investigator: Mohsen Saidinejad, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sub-dissociative Ketamine; Participants receiving 0.25 mg/kg infusion of ketamine	Drug: Sub-dissociative Ketamine Infusion; 0.25 mg/kg of IV ketamine within a 20-minute infusion of 100 milliliters of normal saline (NS)
Placebo Comparator: Normal Saline; Participants receiving 100 milliliters of normal saline	Drug: Normal Saline Placebo Infusion; 20-minute infusion of 100 milliliters of normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score	Pain score from 0-10, at 30 and 60 minutes after administration of NS/placebo (control group), versus sub-dissociative ketamine (experimental group)	30 minutes and 60 minutes after administration of placebo vs ketamine infusion
ED Length of Stay	To compare ED length of stay between control vs experimental group	Up to 3 days
Rate of Hospitalization	To compare rate of hospitalization and length of hospitalization between control and experimental group	Up to 1 month
Quality of Life (Pediatric Quality of Life)	To compare overall quality of life between the two groups upon discharge from the ED or the hospital, using the Pediatric Quality of Life (PedsQL) questionnaire. The questionnaire has 43 points and is reverse scored and linearly transformed to a 0-100 scale (0=100, 1=75, 2=50, 3=25, 4=0), so that higher scores indicate better quality of life.	7-10 days after enrollment in the study and 4-6 weeks after enrollment in the study

Collaborators and Investigators

• Sponsor: Mohsen Saidinejad

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): April 30, 2028

Study Registration Dates

• First Submitted: January 23, 2026
• First Submitted That Met QC Criteria: January 23, 2026
• First Posted (Actual): January 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Sickle Cell Disease; Pediatric Pain Management; Vaso-Occlusive Pain Episode; Sub-Dissociative Ketamine
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Genetic Diseases, Inborn; Neurobehavioral Manifestations; Hematologic Diseases; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hemoglobinopathies; Perceptual Disorders; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hemic and Lymphatic Diseases; Anemia, Sickle Cell; Agnosia; Vaso-Occlusive Crises
• Other Study ID Numbers: 2024-33412-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No