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The Pharmacokinetics of Dexmedetomidine in Children

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ClinicalTrials.gov Identifier: NCT00909935
Recruitment Status : Terminated (unable to enroll enough patients)
First Posted : May 29, 2009
Last Update Posted : June 12, 2017
Sponsor:
Information provided by (Responsible Party):
Keira Mason, Boston Children's Hospital

Tracking Information
First Submitted Date April 30, 2009
First Posted Date May 29, 2009
Last Update Posted Date June 12, 2017
Study Start Date April 2011
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 20, 2013)
Pharmacokinetics of dexmedetomidine in pediatric patients [ Time Frame: 2012-2015 ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Pharmacokinetics of Dexmedetomidine in Children
Official Title The Pharmacokinetics of Dexmedetomidine in Children
Brief Summary This study is designed to identify the plasma concentrations which are required to achieve adequate sedation, using a Ramsay Sedation Scale. As an alpha 2 agonist, dexmedetomidine can elicit hemodynamic changes, fluctuations in blood pressure and heart rate. This study will attempt to determine whether these changes can be predicted by plasma concentrations.
Detailed Description Dexmedetomidine, an alpha2 agonist is currently the standard of care for sedation for diagnostic (MRI, CT and Nuclear Medicine) radiological studies at Boston Children's Hospital. Although it is FDA approved for sedation, its pharmacokinetics in children has not been carefully studied with prospective studies. The plasma concentration of dexmedetomidine necessary to achieve and maintain adequate sedation for motionless conditions for a MRI study has not been determined which is the purpose of this study.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Plasma
Sampling Method Non-Probability Sample
Study Population Children requiring sedation for MRI scanning
Condition MRI Sedation
Intervention Drug: Dexmedetomidine
Initial 2 mcg/kg bolus administered over 10 minutes to achieve the Ramsey sedation score of 4 followed by an infusion of 1.5 mcg/kg/hr, which will run until patient is transferred to recovery area. Up to a further two boluses of 2 mcg/kg may be given to maintain an RSS of 4.
Other Name: Precedex
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Estimated Enrollment
 (submitted: August 1, 2012)
40
Original Estimated Enrollment
 (submitted: May 28, 2009)
250
Actual Study Completion Date August 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Age 3 - 11.9 years

    • 2 age groups: 3.0 - 5.9 years, 6.0 - 11.9 years
  • Patients will be equally distributed within each age group
  • Meets criteria to receive dexmedetomidine sedation for MRI:

    • Active, uncontrolled gastroesophageal reflux - an aspiration risk
    • Active, uncontrolled vomiting - an aspiration risk
    • Current (or within past 3 months) history of apnea requiring an apnea monitor
    • Active, current respiratory issues that are different from the baseline status (pneumonia,exacerbation of asthma, bronchiolitis, respiratory syncytial virus)
    • Unstable cardiac status (life threatening arrhythmias, abnormal cardiac anatomy,significant cardiac dysfunction)
    • Craniofacial anomaly, which could make it difficult to effectively establish a mask airway for positive pressure ventilation if needed
    • Current use of digoxin
    • Moya Moya Disease
    • New-onset stroke
    • Provide written consent to take part in the research study

Exclusion Criteria:

  • Do not meet established sedation criteria
  • History of allergy, intolerance, or reaction to dexmedetomidine or hypersensitivity
  • Previous diagnosis of hepatic insufficiency/failure or a serum glutamate pyruvate transaminase level > 2 times the normal limit determined by Children's Hospital Boston (TCH)
  • Current diagnosis of renal insufficiency/failure or a current serum creatinine level > 1.5 times the normal limit determined by TCH
  • Have received digoxin in the past (no time limit)
  • Received phenobarbital, clonidine or valproic acid within 30 days
  • Current, repaired or risk of Moya-Moya disease
  • Recent stroke (cerebrovascular accident) within past 6 months
  • Uncontrolled hypertension
  • Concomitant use of beta antagonist, or calcium channel blocker
  • Participated in a clinical investigation within the past three months
Sex/Gender
Sexes Eligible for Study: All
Ages 3 Years to 12 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00909935
Other Study ID Numbers 09-02-0067
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Keira Mason, Boston Children's Hospital
Study Sponsor Boston Children's Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Keira P. Mason, MD Boston Children's Hospital
PRS Account Boston Children's Hospital
Verification Date June 2017