Harbor UCLA Medical Center
Torrance, California, 90509, United States
Location status: Recruiting
NCT Number: NCT07369024
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.
Interested in participating?
Request Info5 year–20 year
All sexes
Interventional
Phase 2
Torrance, California, 90509, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
0.25 mg/kg of IV ketamine within a 20-minute infusion of 100 milliliters of normal saline (NS)
20-minute infusion of 100 milliliters of normal saline
Time frame: Up to 3 days
Cumulative morphine-mg equivalent per kilogram (MME/kg) of opioid medication needed to achieve a pain score of ≤ 5
Time frame: 30 minutes and 60 minutes after administration of placebo vs ketamine infusion
Pain score from 0-10, at 30 and 60 minutes after administration of NS/placebo (control group), versus sub-dissociative ketamine (experimental group)
Time frame: Up to 3 days
To compare ED length of stay between control vs experimental group
Time frame: Up to 1 month
To compare rate of hospitalization and length of hospitalization between control and experimental group
Time frame: 7-10 days after enrollment in the study and 4-6 weeks after enrollment in the study
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.
Contact information is provided by the study sponsor or research team.
Cynthia Luo, MD
CONTACT
Mohsen Saidinejad, MD
CONTACT
Mohsen Saidinejad
Other
Sub-dissociative Dose Ketamine in Treatment of Vaso-occlusive Pain Event in Children and Young Adults: A Randomized Control Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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