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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

Study Description
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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.

Condition or disease Intervention/treatment
MRI Sedation Drug: Dexmedetomidine

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 Design
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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Pharmacokinetics of Dexmedetomidine in Children
Study Start Date : April 2011
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
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Intervention Details:
    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

Outcome Measures
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Primary Outcome Measures :
  1. Pharmacokinetics of dexmedetomidine in pediatric patients [ Time Frame: 2012-2015 ]

Biospecimen Retention:   Samples Without DNA
Plasma

Eligibility Criteria
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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children requiring sedation for MRI scanning
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
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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): NCT00909935


Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
Investigators
Principal Investigator: Keira P. Mason, MD Boston Children’s Hospital
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Keira Mason, Senior Associate in Perioperative Anesthesia, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT00909935     History of Changes
Other Study ID Numbers: 09-02-0067
First Posted: May 29, 2009    Key Record Dates
Last Update Posted: June 12, 2017
Last Verified: June 2017

Keywords provided by Keira Mason, Boston Children's Hospital:
To determine pharmacokinetics of dexmedetomidine in children

Additional relevant MeSH terms:
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action