The Pharmacokinetics of Dexmedetomidine in Children
This study is currently recruiting participants.
Verified August 2012 by Children's Hospital Boston
Sponsor:
Children's Hospital Boston
Information provided by (Responsible Party):
Keira Mason, Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00909935
First received: April 30, 2009
Last updated: August 1, 2012
Last verified: August 2012
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Purpose
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 | Intervention |
|---|---|
|
MRI Sedation |
Drug: Dexmedetomidine |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | The Pharmacokinetics of Dexmedetomidine in Children |
Resource links provided by NLM:
Further study details as provided by Children's Hospital Boston:
Biospecimen Retention: Samples Without DNA
Plasma
| Estimated Enrollment: | 40 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
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.
Other Name: Precedex
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| Ages Eligible for Study: | 3 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Children requiring sedation for MRI scanning
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00909935
Contacts
| Contact: Vanessa Young, RN, BA | vanessa.young@childrens.harvard.edu |
Locations
| United States, Massachusetts | |
| Children's Hospital Boston | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Keira Mason Keira.Mason@childrens.harvard.edu | |
| Contact: Vanessa Young vanessa.young@childrens.harvard.edu | |
| Principal Investigator: Keira P Mason, MD | |
| Sub-Investigator: Randy Prescilla, MD | |
| Sub-Investigator: Vanessa Young | |
| Sub-Investigator: Justine Bode | |
Sponsors and Collaborators
Children's Hospital Boston
Investigators
| Principal Investigator: | Keira P. Mason, MD | Children's Hospital Boston |
More Information
No publications provided
| Responsible Party: | Keira Mason, Senior Associate in Perioperative Anesthesia, Children's Hospital Boston |
| ClinicalTrials.gov Identifier: | NCT00909935 History of Changes |
| Other Study ID Numbers: | 09-02-0067 |
| Study First Received: | April 30, 2009 |
| Last Updated: | August 1, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Children's Hospital Boston:
|
To determine pharmacokinetics of dexmedetomidine in children |
Additional relevant MeSH terms:
|
Dexmedetomidine Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses 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 |
ClinicalTrials.gov processed this record on May 19, 2013