Adjuvant Low-dose Ketamine in Pediatric Sickle Cell Vaso-occlusive Crisis (AKTSS)
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ClinicalTrials.gov Identifier: NCT03296345 |
Recruitment Status :
Completed
First Posted : September 28, 2017
Results First Posted : April 20, 2021
Last Update Posted : April 20, 2021
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Condition or disease | Intervention/treatment | Phase |
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Sickle Cell Disease Vaso-Occlusive Crisis | Drug: Ketamine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 62 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Adjuvant Low-dose Ketamine in Pediatric Sickle Cell Vaso-occlusive Crisis (AKTSS) |
Study Start Date : | June 2016 |
Actual Primary Completion Date : | April 2018 |
Actual Study Completion Date : | April 2018 |

Arm | Intervention/treatment |
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Active Comparator: Intervention
Prior to the second dose of IV opiates, the experiment was to give patients a single IV bolus of ketamine at the dose of 0.2 mg/kg. Pain scores were collected using the FACES scale currently in place. In consenting patients, chart review was performed with the following data collected: mg/kg/hour of morphine equivalents, pain scores on admission, during the encounter, and at discharge, the time to 50% pain reduction, and whether or not the patient was discharged. In addition, a survey, which is attached, was 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. |
Drug: Ketamine
The intervention is IV low-dose bolus ketamine as an adjuvant to standard therapy (IV opiates and NSAIDs).
Other Name: Ketalar |
No Intervention: Historical Control
Patient data from at least one but up three patient encounters within the prior year were compared to their visit in which they were given adjuvant ketamine, using the outcome measures in the "Intervention" arm. Since this a historical control study, patients acted as their own controls in the above manner. Patients were allowed to re-enroll 4 weeks after presentation, which is typically considered a separate vaso-occlusive episode in the literature.
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- Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 18 months ]The number of serious and minor adverse events was measured via patient-completed survey as well as by nurse and medical providers on presentation to the emergency department (ED). 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. Both study providers and patients themselves, via a survey that the parent and/or patient (based on age) fills out post receipt of ketamine, reported serious and minor adverse events.
- Effect of Low-dose Ketamine (LDK) on Opioid Usage in the ED [ Time Frame: Up to one year prior and after LDK administration on day 1 of the study in the ED ]Opioid usage for at least one but up to three prior patient visits in the last one year for each patient enrolled in the study was summarized, expressed as morphine equivalents in mg/kg/h, to account for different types of opioids used per patient preference, and then this was compared to the intervention group that received LDK. Percent change in opioid usage (expressed as morphine equivalents in mg/kg/h) is reported).
- Effect of Low-dose Ketamine on Pain Scores on Presentation to the ED [ Time Frame: Up to one year prior and on presentation to the ED after LDK administration ]Patient pain scores at presentation for the enrolled encounters and for at least one but up to three visits prior to receipt of ketamine in the last one year, were assessed. At least one but up to three prior visits were averaged and compared to the intervention visit. Pain was assessed using the faces pain scale which consists of a series of line diagrams of faces with expressions of increasing distress. The score ranges from 0 (no pain) to 10 (the worst pain).
- Effect of Low-dose Ketamine on Discharge Rates From the ED [ Time Frame: Up to one year prior to receipt of ketamine for the historical control arm/group and up to 18 months for the intervention arm/group ]Percent discharge from the ED for intervention group and for at least one but up to three visits prior to receipt of ketamine in the last one year, were assessed. Participants were assigned a "0" if discharged or "1" if not discharged.
- Subjective Effect of Low Dose Ketamine on Pain Relief Assessed Via a Patient Survey [ Time Frame: after LDK administration on day 1 of the study in the ED ]
After receipt of LDK, patients and/or their parents, based on age, filled out a survey based on a Likert scale regarding their agreement (Strongly Disagree to Strongly Agree) with the following statements: Achieved faster pain relief with LDK, Achieved more complete pain relief with LDK, and Desire to receive LDK in a future vaso-occlusive crisis. There is also an area where patients could provide general comments regarding their experience in receiving LDK.
Count of Participants who agree or strongly agree for each question are reported.
- Effect of Low-dose Ketamine on Patient Pain Scores on Discharge From the ED/Admission to the Hospital [ Time Frame: At time of discharge from the ED/admission to the hospital (up to one year prior and after LDK administration) ]Patient pain scores at time of discharge from the ED/admission to the hospital for at least one but up to three visits prior to receipt of ketamine in the last one year, were assessed. At least one but up to three prior visits were averaged and compared to the intervention visit. Pain scores post receipt of ketamine are presented for the intervention group. Pain was assessed using the faces pain scale which consists of a series of line diagrams of faces with expressions of increasing distress. The score ranges from 0 (no pain) to 10 (the worst pain).
- Effect of Low-dose Ketamine on Percent Difference of Length of Stay (LOS) in the ED [ Time Frame: Up to one year prior to and after LDK administration on day 1 of the study in the ED ]Length of stay (LOS) in minutes in the ED for at least one but up to three visits prior to receipt of ketamine in the last one year, were assessed.
- Effect of Low-dose Ketamine on Time to 50% Pain Reduction [ Time Frame: Up to one year prior to and after LDK administration on day 1 of the study in the ED ]Time to 50% pain reduction (pain reported 50% less than baseline) in minutes for at least one but up to three visits prior to receipt of ketamine in the last one year, were assessed as historical controls. Pain was assessed using the faces pain scale which consists of a series of line diagrams of faces with expressions of increasing distress. The score ranges from 0 (no pain) to 10 (the worst pain).

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Ages Eligible for Study: | 10 Years to 25 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

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
United States, California | |
UCSF Benioff Children's Hospital and Research Center Oakland | |
Oakland, California, United States, 94609 |
Principal Investigator: | Jonathan B Cooper-Sood, MD | Children's Hospital and Research Center of Oakland |
Documents provided by UCSF Benioff Children's Hospital Oakland:
Responsible Party: | UCSF Benioff Children's Hospital Oakland |
ClinicalTrials.gov Identifier: | NCT03296345 |
Other Study ID Numbers: |
2010-010 |
First Posted: | September 28, 2017 Key Record Dates |
Results First Posted: | April 20, 2021 |
Last Update Posted: | April 20, 2021 |
Last Verified: | March 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Ketamine Sickle Cell Disease Vaso-Occlusive Episode |
Anemia, Sickle Cell Anemia, Hemolytic, Congenital Anemia, Hemolytic Anemia Hematologic Diseases Hemoglobinopathies Genetic Diseases, Inborn Ketamine Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Anesthetics, Dissociative Anesthetics, Intravenous Anesthetics, General Anesthetics Central Nervous System Depressants Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |