Adjuvant Low-dose Ketamine in Pediatric Sickle Cell Vaso-occlusive Crisis (AKTSS)
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|ClinicalTrials.gov Identifier: NCT03296345|
Recruitment Status : Recruiting
First Posted : September 28, 2017
Last Update Posted : September 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Sickle Cell Disease Vaso-Occlusive Crisis||Drug: Ketamine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Adjuvant Low-dose Ketamine in Pediatric Sickle Cell Vaso-occlusive Crisis (AKTSS)|
|Study Start Date :||June 2016|
|Actual Primary Completion Date :||January 2017|
|Estimated Study Completion Date :||December 2018|
Active Comparator: Intervention
Prior to the second dose of IV opiates, the experiment will be to give patients a single IV bolus of ketamine at the dose of 0.2 mg/kg. Pain scores will be collected using the FACES scale currently in place. In consenting patients, chart review will be performed with the following data being collected: mg/kg/hour of morphine equivalents, pain scores on admission, during the encounter, and at discharge, the time to 50% pain reduction, whether or not the patient was discharged, and if re-presentation occurred in the subsequent 3 months.
In addition, a survey, which is attached, will be given to patients/families at the time of drug administration to determine if they experienced a subjective improvement in their pain and if they suffered any undue side effects due to drug administration.
The intervention is IV low-dose bolus ketamine as an adjuvant to standard therapy (IV opiates and NSAIDs).
No Intervention: Historical Control
Patient data from at least one but up to as many as are available within the last year will be summed and compared to their visit where they were given adjuvant ketamine, using the outcome measures in the "Intervention" arm. Since this a historical control study, patients act as their own controls in the above manner. Patients are allowed to re-enroll 4 weeks after presentation, which is typically considered a second vaso-occlusive crisis in the literature.
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 6 months ]Serious adverse events are defined as cardiorespiratory events requiring intervention. Minor adverse events are defined as nausea/vomiting, emergence reaction (dysphoria; hallucinations; frightening dreams), and a sense of de-realization or "dreamy" sensation. The incidence of treatment-emergence adverse events will be expressed in percentages and reviewed by our DSMB and IRB, in comparison to the incidence of treatment-emergent adverse events published in the adult literature (none currently exists in the pediatric literature for comparison). Both study providers and patients themselves, via a survey that the parent and/or patient (based on age) fills out post receipt of ketamine, will report serious and minor adverse events. Per the decision of the UCSF Benioff Children's Hospital and Research Center of Oakland IRB and Research Committee, at least 30 patients are required to complete this outcome.
- Effect of low-dose ketamine on opiate usage in the ED [ Time Frame: Up to 18 months ]Opiate usage for at least one but up to as many available prior patient visits in the last one year for each patient enrolled in the study will be summarized, expressed as morphine equivalents in mg/kg/h, to account for different types of opiates used per patient preference and time spent in the ED. This will be compared via a t-test to determine if a significant difference exists pre and post intervention with ketamine. To detect a 20% difference, 90 patients must be enrolled.
- Effect of low-dose ketamine on pain scores in the ED [ Time Frame: Up to 18 months ]Patient pain scores at presentation, discharge from the ED/admission to the hospital, and time to 50% pain reduction in minutes for at least one but up to as many patient encounters prior to receipt of ketamine in the last one year, will be assessed. Pain scores and time to pain reduction as above will be compared via a t-test pre and post receipt of ketamine.
- Effect of low-dose ketamine on hospitalization and discharge rates from the ED [ Time Frame: Up to 18 months ]The average hospitalization and discharge rates, expressed as percentages, for all patients in the study pre and post receipt of ketamine will be calculated. These will be compared via a t-test to determine if a significant difference exists.
- Subjective effect of low dose ketamine on pain relief assessed via a patient survey [ Time Frame: Up to 18 months ]After receipt of ketamine, patients and/or their parents, based on age, will fill out a survey based on a Likert scale regarding their agreement with the following questions: if ketamine relieved their pain faster, if ketamine relieved their pain more completely, and if they would like to receive ketamine for a future vaso-occlusive crisis. There is also an area where patients can provide general comments regarding their experience in receiving ketamine.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03296345
|Contact: Bryan Cooper-Sood, MDfirstname.lastname@example.org|
|Contact: Anurag Agrawal, MD||5104283539||AAgrawal@mail.cho.org|
|United States, California|
|UCSF Benioff Children's Hospital and Research Center Oakland||Recruiting|
|Oakland, California, United States, 94609|
|Contact: Bryan Cooper-Sood, MD 510-428-3888 email@example.com|
|Contact: Anurag Agrawal, MD 5104283539 AAgrawal@mail.cho.org|
|Principal Investigator: Bryan Cooper-Sood, MD|
|Sub-Investigator: Anurag Agrawal, MD|
|Sub-Investigator: Carolyn Hoppe, MD|
|Sub-Investigator: James Naprawa, MD|
|Sub-Investigator: Anne Marsh, MD|