Adjuvant Low-dose Ketamine in Pediatric Sickle Cell Vaso-occlusive Crisis
Completed · Phase 2
Conditions studied: Sickle Cell Disease, Vaso-Occlusive Crisis
In brief
Acute vaso-occlusive episodes (VOEs) in sickle cell disease (SCD) are primarily managed with opioids. Tolerance and hyperalgesia to opioids develops due to N-methyl-D-aspartate (NMDA)-receptor mediated activation of the nociceptive system, and as a receptor antagonist, ketamine mitigates this. Intravenous (IV) ketamine has demonstrated efficacy in reducing post-operative, chronic, and cancer-related pain in pediatrics, as well as in reducing time to pain control in the emergency department (ED) in adults. Limited studies suggest efficacy in adult opioid-refractory SCD patients. This study is investigating the safety and tolerability of adjuvant low-dose IV ketamine bolus for pediatric SCD VOE in the ED, as well as its efficacy in improving pain control and reducing hospitalization.
Key facts
- Study ID
- NCT03296345
- Run by
- UCSF Benioff Children's Hospital Oakland
- People needed
- 62
- Starts
- 2016-06-01
- Expected to finish
- 2018-04-01
- Last updated by the study team
- 2021-04-20
Who can join
Age: 10 and older, up to 25. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- All English-speaking, sickle cell patients who receive their care at UCSFBCHO in the Department of Hematology who are 8-to-25-years-old presenting to the emergency department for VOC were asked to enroll.
You may not qualify if…
- Prior adverse reaction to ketamine
- Patients were asked during the consent process if they have ever received ketamine, and if so, if they had any serious adverse reaction, such as difficulty breathing, dysphoria, hallucinations, or allergic reaction. If they have, ketamine was not given to these patients.
- Patients who have received ketamine and experienced nausea or vomiting will be asked if they wish to receive the medication. If they do not, they did not receive ketamine.
Where it is running
- UCSF Benioff Children's Hospital and Research Center Oakland — Oakland, California, United States
Full record on ClinicalTrials.gov
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