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.

Study Overview

• Status: Terminated
• Conditions: MRI Sedation
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Children's Hospital Boston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children requiring sedation for MRI scanning

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics of dexmedetomidine in pediatric patients	2012-2015

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Investigators: Principal Investigator: Keira P. Mason, MD, Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: April 30, 2009
• First Submitted That Met QC Criteria: May 28, 2009
• First Posted (Estimate): May 29, 2009

Study Record Updates

• Last Update Posted (Actual): June 12, 2017
• Last Update Submitted That Met QC Criteria: June 8, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: To determine pharmacokinetics of dexmedetomidine in children
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: 09-02-0067