The Pharmacokinetics of Dexmedetomidine in Children

• Status: Terminated
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Children's Hospital; Boston Children’s Hospital
• Treatments: Dexmedetomidine

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