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



Status:Recruiting
Conditions:Anemia
Therapuetic Areas:Hematology
Healthy:No
Age Range:8 - 25
Updated:9/30/2017
Start Date:June 2016
End Date:December 2018
Contact:Bryan Cooper-Sood, MD
Email:jocooper@mail.cho.org
Phone:5104283888

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

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.

In this cohort study, all consenting pediatric sickle-cell patients between 10 and 25 years
old who are cared for at UCSF Benioff Children's Hospital Oakland (UCSFBCHO) presenting to
the emergency department for VOC will be enrolled in the study. Patients will be 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 will be 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 will be summed in the ED, converted to mg/kg/hour of morphine
equivalents (since different opiate agents are 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, the proportion of discharged vs admitted patients, pain scores at
admission, during the visit, and discharge, and proportion of patients re-presenting for
care, will all be compared in the pre and post intervention groups. Data will 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) will be compared to
the post intervention data. In addition, a survey, which is attached, will be 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.

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 will be asked to enroll.

Exclusion Criteria:

- Prior adverse reaction to ketamine.

- Patients will be 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 will not be
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 will not receive
ketamine.
We found this trial at
1
site
747 52nd Street
Oakland, California 94609
Principal Investigator: Bryan Cooper-Sood, MD
Phone: 510-428-3888
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mi
from
Oakland, CA
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