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The Pharmacokinetics of Dexmedetomidine in Children

NCT00909935 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2017-06-12

No results posted yet for this study

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.

Conditions

  • MRI Sedation

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Keira P. Mason, MD · Boston Children's Hospital

Eligibility

Min Age
3 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00909935 on ClinicalTrials.gov