Sub-dissociative Dose Ketamine in Treatment of Vaso-occlusive Pain Event in Children and Young Adults: A Randomized Control Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 20
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
Harbor UCLA Medical Center
RECRUITING
Torrance
Contact Information
Primary
Cynthia Luo, MD
cluo2@dhs.lacounty.gov
310-222-2345
Backup
Mohsen Saidinejad, MD
moh@emedharbor.edu
Time Frame
Start Date: 2026-01
Estimated Completion Date: 2028-01
Participants
Target number of participants: 120
Treatments
Experimental: Sub-dissociative Ketamine
Participants receiving 0.25 mg/kg infusion of ketamine
Placebo_comparator: Normal Saline
Participants receiving 100 milliliters of normal saline
Sponsors
Leads: Mohsen Saidinejad

This content was sourced from clinicaltrials.gov