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
About this trial
This is an interventional treatment trial for Sickle Cell Disease
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.
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
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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