The Pharmacokinetics of Dexmedetomidine in Children - Full Text View

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:

Drug Information available for: Dexmedetomidine Dexmedetomidine hydrochloride

U.S. FDA Resources

Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:

Pharmacokinetics of dexmedetomidine in pediatric patients [ Time Frame: 2012-2015 ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Plasma


Estimated Enrollment:	40
Study Start Date:	April 2011
Estimated Study Completion Date:	December 2015
Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Intervention Details:

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

Detailed Description:

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00909935

Locations


United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115

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:	January 30, 2015
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 Adrenergic Agents Adrenergic Agonists Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Analgesics Analgesics, Non-Narcotic Central Nervous System Agents Central Nervous System Depressants	Hypnotics and Sedatives Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Sensory System Agents Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015