CompletedPhase 2ketamine

Adjuvant Low-dose Ketamine in Pediatric Sickle Cell Vaso-occlusive Crisis

Sponsored by UCSF Benioff Children's Hospital Oakland

NCT ID
NCT03296345
Target Enrollment
62 participants
Start Date
2016-06
Est. Completion
2018-04

About This Study

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.

Conditions Studied

Sickle Cell DiseaseVaso-Occlusive Crisis

Interventions

  • Ketamine

Eligibility

Age:10 Years - 25 Years
Healthy Volunteers:Yes
View full eligibility criteria
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Study Locations (1)

UCSF Benioff Children's Hospital and Research Center Oakland
Oakland, California, United States

This trial is not recruiting

This study has completed enrollment. Check back for results or find similar trials.

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Data Source
ClinicalTrials.gov

Last updated from source