The Pharmacokinetics of Dexmedetomidine in Children

This study is currently recruiting participants.
Verified December 2013 by Children's Hospital Boston
Sponsor:
Information provided by (Responsible Party):
Keira Mason, Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00909935
First received: April 30, 2009
Last updated: December 20, 2013
Last verified: December 2013

April 30, 2009
December 20, 2013
April 2011
December 2014   (final data collection date for primary outcome measure)
Pharmacokinetics of dexmedetomidine in pediatric patients [ Time Frame: 2012-2015 ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00909935 on ClinicalTrials.gov Archive Site
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The Pharmacokinetics of Dexmedetomidine in Children
The Pharmacokinetics of Dexmedetomidine in Children

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Plasma

Non-Probability Sample

Children requiring sedation for MRI scanning

MRI Sedation
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
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
December 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
3 Years to 12 Years
No
Contact: Vanessa Young, RN, BA vanessa.young@childrens.harvard.edu
United States
 
NCT00909935
09-02-0067
Yes
Keira Mason, Children's Hospital Boston
Children's Hospital Boston
Not Provided
Principal Investigator: Keira P. Mason, MD Children's Hospital Boston
Children's Hospital Boston
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP