drugset / Trial / NCT03296345

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

NCT03296345

Phase 2 Completed 62 enrolled UCSF Benioff Children's Hospital Oakland
Non-randomizedSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2016-06
Primary completion
2018-04
Completion
2018-04

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ketamine Small molecule 0.2 mg/kg Intravenous

Indications