Clinical trial NCT00909935: The Pharmacokinetics of Dexmedetomidine in Children
Official title: The Pharmacokinetics of Dexmedetomidine in Children
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: MRI Sedation
Keywords: To determine pharmacokinetics of dexmedetomidine in children
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2009-05-29
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children requiring sedation for MRI scanning

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.

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

Primary outcomes:
measure: Pharmacokinetics of dexmedetomidine in pediatric patients
timeFrame: 2012-2015
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Keira P. Mason, MD
role: PRINCIPAL_INVESTIGATOR
References: