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
  Purpose

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 Intervention
MRI Sedation
Drug: Dexmedetomidine

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Pharmacokinetics of Dexmedetomidine in Children

Resource links provided by NLM:


Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • Pharmacokinetics of dexmedetomidine in pediatric patients [ Time Frame: 2012-2015 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Plasma


Estimated Enrollment: 40
Study Start Date: April 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Ages Eligible for Study:   3 Years to 12 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00909935

Contacts
Contact: Vanessa Young, RN, BA vanessa.young@childrens.harvard.edu

Locations
United States, Massachusetts
Children's Hospital Boston Recruiting
Boston, Massachusetts, United States, 02115
Contact: Keira Mason       Keira.Mason@childrens.harvard.edu   
Contact: Vanessa Young       vanessa.young@childrens.harvard.edu   
Principal Investigator: Keira P Mason, MD         
Sub-Investigator: Randy Prescilla, MD         
Sub-Investigator: Vanessa Young         
Sub-Investigator: Justine Bode         
Sponsors and Collaborators
Children's Hospital Boston
Investigators
Principal Investigator: Keira P. Mason, MD Children's Hospital Boston
  More Information

No publications provided

Responsible Party: Keira Mason, Senior Associate in Perioperative Anesthesia, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT00909935     History of Changes
Other Study ID Numbers: 09-02-0067
Study First Received: April 30, 2009
Last Updated: December 20, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
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

ClinicalTrials.gov processed this record on April 16, 2014