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Ketamine as an Adjuvant Therapy for Acute Vaso Occlusive Crisis in Pediatric Patients With Sickle Cell Disease (KSickle)

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ClinicalTrials.gov Identifier: NCT02801292
Recruitment Status : Unknown
Verified June 2016 by Augusta University.
Recruitment status was:  Not yet recruiting
First Posted : June 15, 2016
Last Update Posted : June 15, 2016
Sponsor:
Information provided by (Responsible Party):
Augusta University

Study Description
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Brief Summary:
The primary objective of the proposed study is to determine the potential role of Ketamine as an analgesic agent in pediatric sickle cell disease patients with refractory symptoms in acute (VOC).

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Drug: Ketamine Phase 3

Detailed Description:
The primary objective of the proposed study is to determine the potential role of Ketamine as an analgesic agent in pediatric sickle cell disease patients with refractory symptoms in acute (VOC). Our study design is as follows: Prospective observational study of 20 pediatric sickle cell disease patients with refractory pain to conventional analgesic regimens seen in the pediatric emergency medicine department. Consenting patients with refractory pain meeting inclusion criteria will be given a single intravenous bolus of Ketamine at a set dosage of 0.25 milligrams per kilogram of weight. Participants' perception of pain will then be recorded using standard pain scoring scales (FLACC score). Physiologic criteria such as heart rate, blood pressure, blood oxygen saturation, total analgesic pharmacologic requirements for adequate analgesia during hospitalization, and duration of hospitalization will be measured. Observational study group will continue to get standard of care outside of single bolus of Ketamine. 48 hour follow up after hospital discharge will be obtained to assess degree of pain control and general clinical status.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ketamine as an Adjuvant Therapy for Acute Vaso Occlusive Crisis in Pediatric Patients With Sickle Cell Disease, a Pilot Study
Study Start Date : July 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arms and Interventions
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Arm Intervention/treatment
administering of ketamine
adjuvant to standard of care
 Drug: Ketamine
Single bolus of Ketamine .25 milligrams per kilogram of weight.
Other Name: ketamine hydrochloride


Outcome Measures
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Primary Outcome Measures :
  1. pain score [ Time Frame: 1 hour ]
    reduction in refractory pain


Eligibility Criteria
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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pediatric patients (> 3 yrs and <18yrs) with a previous diagnosis of sickle cell disease (including Hgb S Beta Thalassemia +, Hgb S Alpha Thalassemia, Hgb S HPFH) ) seen in the pediatric emergency room setting for acute vaso-occlusive pain crisis.

Exclusion Criteria:

  • Patients not to have sequelae indicative of complicated disease outside of acute VOC:

    1. Acute chest syndrome (new pulmonary infiltrate and hypoxemia)
    2. Aplastic Episode
    3. Evidence of infection
    4. Pregnancy or CHF
    5. Fever (> 38.4)
    6. Cholangitis or cholecystitis
    7. Hypoxia (SaO2 <90% on RA), or O2 saturation decrease of more than 5% from patient's baseline
    8. Unstable Vital Signs
    9. Patients who have received intravenous pain medicine within 24 hours of visit to the emergency department.
    10. History of allergic reaction or serious reaction to Ketamine.
    11. History of significant psychiatric illness
    12. Patients with no refractory pain after receiving conventional analgesia regimen per protocol.
Contacts and Locations
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Information from the National Library of Medicine

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): NCT02801292


Contacts
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Contact: George Hsu, MD 404-556-7250 ghsu@augusta.edu
Contact: Natalie Lane, MD 706-721-4467 nlane@augusta.edu

Sponsors and Collaborators
Augusta University
Investigators
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Principal Investigator: George Hsu, MD Augusta University
More Information
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Publications:

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Responsible Party: Augusta University
ClinicalTrials.gov Identifier: NCT02801292    
Other Study ID Numbers: 917282
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: June 15, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared
Additional relevant MeSH terms:
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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