The Pharmacokinetics of Dexmedetomidine in Children
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ClinicalTrials.gov Identifier: NCT00909935 |
Recruitment Status
:
Terminated
(unable to enroll enough patients)
First Posted
: May 29, 2009
Last Update Posted
: June 12, 2017
|
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Condition or disease | Intervention/treatment |
---|---|
MRI Sedation | Drug: Dexmedetomidine |
Study Type : | Observational |
Estimated Enrollment : | 40 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | The Pharmacokinetics of Dexmedetomidine in Children |
Study Start Date : | April 2011 |
Actual Primary Completion Date : | August 2013 |
Actual Study Completion Date : | August 2013 |

-
Drug: Dexmedetomidine
- Pharmacokinetics of dexmedetomidine in pediatric patients [ Time Frame: 2012-2015 ]
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 3 Years to 12 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00909935
United States, Massachusetts | |
Children's Hospital Boston | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Keira P. Mason, MD | Boston Children’s Hospital |
Responsible Party: | Keira Mason, Senior Associate in Perioperative Anesthesia, Boston Children's Hospital |
ClinicalTrials.gov Identifier: | NCT00909935 History of Changes |
Other Study ID Numbers: |
09-02-0067 |
First Posted: | May 29, 2009 Key Record Dates |
Last Update Posted: | June 12, 2017 |
Last Verified: | June 2017 |
Keywords provided by Keira Mason, Boston Children's Hospital:
To determine pharmacokinetics of dexmedetomidine in children |
Additional relevant MeSH terms:
Dexmedetomidine Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Analgesics, Non-Narcotic Analgesics Sensory System Agents |
Peripheral Nervous System Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |