Adjuvant Low-dose Ketamine in Pediatric Sickle Cell Vaso-occlusive Crisis
Condition: Sickle Cell Disease; Vaso-Occlusive Crisis
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      In this cohort study, all consenting pediatric sickle-cell patients between 10 and 25 years
      old who were cared for at UCSF Benioff Children's Hospital Oakland (UCSFBCHO) presenting to
      the emergency department for VOC were enrolled in the study. Patients were compared to
      themselves in a time series, pre and post exposure to the study intervention (low-dose
      ketamine bolus at 0.2 mg/kg x 1 prior to second dose of IV opiate). The pediatric FACES pain
      scale was used to measure pain scales at pre-designated time points in the ED per standard
      nursing protocol (FACES for younger kids, visual analog scale in adolescents/young adults).
      Opiate usage was summed in the ED, converted to mg/kg/hour of morphine equivalents (since
      different opioids agents were given to different patients based on individual historical
      efficacy, and since length of stay in the emergency room could affect total morphine
      equivalents received), and compared between the pre and post-intervention groups. In
      addition, length of stay, time to 50% pain control, presentation and discharge pain scores,
      and likelihood of discharge from the ED were compared. Data was be collected via chart review
      in the UCSFBCHO system by study investigators. Pre-intervention data from the past three
      patient encounters (e.g., the mean of the mg/kg/hour of morphine equivalents used in the last
      three patient encounters prior to receipt of ketamine) was compared to the post intervention
      data. In addition, a survey, which is attached, was given to patients/families at the time of
      the drug administration to attempt to discern if patients subjectively experienced
      improvement in their pain and if they experienced any negative side effects due to the drug
      administration. Monitoring for adverse events was recorded for each patient encounter.
    

Intervention name(s): Ketamine
Intervention type(s): Drug
Intervention description(s): The intervention is IV low-dose bolus ketamine as an adjuvant to standard therapy (IV opiates and NSAIDs).
Other intervention name(s): Ketalar
Intervention MeSH terms: Ketamine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ketamine; Sickle Cell Disease; Vaso-Occlusive Episode