The Pharmacokinetics of Dexmedetomidine in Children
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ClinicalTrials.gov Identifier: NCT00909935
Recruitment Status :
(unable to enroll enough patients)
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
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.
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.
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Layout table for eligibility information
Ages Eligible for Study:
3 Years to 12 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Children requiring sedation for MRI scanning
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)