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

Primary Purpose

Sickle Cell Disease

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Ketamine
Sponsored by
Augusta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sickle Cell Disease

Eligibility Criteria

3 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    administering of ketamine

    Arm Description

    adjuvant to standard of care

    Outcomes

    Primary Outcome Measures

    pain score
    reduction in refractory pain

    Secondary Outcome Measures

    Full Information

    First Posted
    June 10, 2016
    Last Updated
    June 10, 2016
    Sponsor
    Augusta University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02801292
    Brief Title
    Ketamine as an Adjuvant Therapy for Acute Vaso Occlusive Crisis in Pediatric Patients With Sickle Cell Disease
    Acronym
    KSickle
    Official Title
    Ketamine as an Adjuvant Therapy for Acute Vaso Occlusive Crisis in Pediatric Patients With Sickle Cell Disease, a Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2016 (undefined)
    Primary Completion Date
    July 2018 (Anticipated)
    Study Completion Date
    July 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Augusta University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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).
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sickle Cell Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    administering of ketamine
    Arm Type
    Other
    Arm Description
    adjuvant to standard of care
    Intervention Type
    Drug
    Intervention Name(s)
    Ketamine
    Other Intervention Name(s)
    ketamine hydrochloride
    Intervention Description
    Single bolus of Ketamine .25 milligrams per kilogram of weight.
    Primary Outcome Measure Information:
    Title
    pain score
    Description
    reduction in refractory pain
    Time Frame
    1 hour

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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: Acute chest syndrome (new pulmonary infiltrate and hypoxemia) Aplastic Episode Evidence of infection Pregnancy or CHF Fever (> 38.4) Cholangitis or cholecystitis Hypoxia (SaO2 <90% on RA), or O2 saturation decrease of more than 5% from patient's baseline Unstable Vital Signs Patients who have received intravenous pain medicine within 24 hours of visit to the emergency department. History of allergic reaction or serious reaction to Ketamine. History of significant psychiatric illness Patients with no refractory pain after receiving conventional analgesia regimen per protocol.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    George Hsu, MD
    Phone
    404-556-7250
    Email
    ghsu@augusta.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Natalie Lane, MD
    Phone
    706-721-4467
    Email
    nlane@augusta.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    George Hsu, MD
    Organizational Affiliation
    Augusta University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    IPD will not be shared
    Citations:
    PubMed Identifier
    1710777
    Citation
    Platt OS, Thorington BD, Brambilla DJ, Milner PF, Rosse WF, Vichinsky E, Kinney TR. Pain in sickle cell disease. Rates and risk factors. N Engl J Med. 1991 Jul 4;325(1):11-6. doi: 10.1056/NEJM199107043250103.
    Results Reference
    background
    PubMed Identifier
    12826855
    Citation
    Koppert W, Sittl R, Scheuber K, Alsheimer M, Schmelz M, Schuttler J. Differential modulation of remifentanil-induced analgesia and postinfusion hyperalgesia by S-ketamine and clonidine in humans. Anesthesiology. 2003 Jul;99(1):152-9. doi: 10.1097/00000542-200307000-00025.
    Results Reference
    background
    PubMed Identifier
    8657426
    Citation
    Mao J, Price DD, Mayer DJ. Mechanisms of hyperalgesia and morphine tolerance: a current view of their possible interactions. Pain. 1995 Sep;62(3):259-274. doi: 10.1016/0304-3959(95)00073-2.
    Results Reference
    background
    PubMed Identifier
    10551055
    Citation
    Bergman SA. Ketamine: review of its pharmacology and its use in pediatric anesthesia. Anesth Prog. 1999 Winter;46(1):10-20.
    Results Reference
    background

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

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