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Sponsored by: |
Hospira, Inc. |
---|---|
Information provided by: | Hospira, Inc. |
ClinicalTrials.gov Identifier: | NCT00652028 |
The objective of this study is to characterize the pharmacokinetic and pharmacodynamic profile of dexmedetomidine administered as an intravenous bolus followed by a continuous intravenous infusion in pediatric subjects ages greater than or equal to 2 through < 17 years old.
Condition | Intervention | Phase |
---|---|---|
Intubated and Mechanically Ventilated Pediatric Subjects |
Drug: midazolam; fentanyl |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | A Phase II, Open-Label, Multicenter, Escalating Dose, Study to Determine Pharmacokinetic and Pharmacodynamic Profile of Dexmedetomidine in Pediatric Subjects Ages > 2 Through < 17 Years Old |
Estimated Enrollment: | 56 |
Study Start Date: | August 2008 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Group 1
Dose level 1
|
Drug: midazolam; fentanyl
Midazolam for sedation according to label; fentanyl for pain according to the label
|
Group 2
Dose level 2
|
Drug: midazolam; fentanyl
Midazolam for sedation according to label; fentanyl for pain according to the label
|
Group 3
Dose level 3
|
Drug: midazolam; fentanyl
Midazolam for sedation according to label; fentanyl for pain according to the label
|
Group 4
Dose level 4
|
Drug: midazolam; fentanyl
Midazolam for sedation according to label; fentanyl for pain according to the label
|
This is a phase II, open-label, multicenter, escalating dose study evaluating the pharmacokinetics and pharmacodynamics of dexmedetomidine in pediatric subjects. The study population consists of initially intubated and mechanically ventilated pediatric subjects, ages > or equal to 2 through < 17 years old, that require sedation in an intensive care setting for a minimum of 6 hours. Subjects will be divided into two groups based on age: Group I will consist of subjects ages > or equal to 2 through < 6 years old and Group II subjects age > or equal to 6 through < 17 years old. Within each group there will be four escalating dosing levels. Both groups can enroll simultaneously; however within each group, the next dose level cannot begin to enroll until all subjects have completed the previous dose level and the Data Safety Monitoring Board (DSMB) has approved enrollment to the next level. The level of sedation will be assessed using the Ramsay Sedation Scale (RSS). Based on these scores, and clinical judgment, additional sedation with midazolam will be administered according to the label. Pain will be assessed using the Faces, Legs, Arms, Cry & Consolability (FLACC) scale. Venous blood samples for pharmacokinetic analysis will be obtained at designated times. The pharmacodynamic and safety measures that will be monitored and the pharmacodynamic impact of dexmedetomidine on tracheal extubation will also be explored if subject is extubated within 24 hours.
Ages Eligible for Study: | 2 Years to 16 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Age: subjects must fit into one of the following age ranges at screening:
If female, subject is non-lactating and is either:
Exclusion Criteria:
Contact: Katie Weber | 224-212-4633 | katie.weber@hospira.com |
Contact: Valerie Bell | 224-212-4726 | valerie.bell@hospira.com |
United States, New York | |
Children's Hospital of Buffalo | Recruiting |
Buffalo, New York, United States, 14222 | |
United States, North Carolina | |
Duke University Medical Center | Recruiting |
Durham, North Carolina, United States, 27710 | |
United States, Ohio | |
Rainbow Babies and Children's Hospital | Recruiting |
Cleveland, Ohio, United States, 44106 | |
United States, Pennsylvania | |
Children's Hospital of Philadelphia | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Children's Hospital of Pittsburgh | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Guatemala | |
Unidad Cirugia Cardiovascular de Guatemala | Recruiting |
Guatemala City, Guatemala |
Responsible Party: | Hospira, Inc. ( Paula Bokesch, MD ) |
Study ID Numbers: | DEX-08-01 |
Study First Received: | April 1, 2008 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00652028 |
Health Authority: | United States: Food and Drug Administration |
Pharmacokinetics Pharmacodynamics Escalating dose Dexmedotimidine |
Intubated Mechanically ventilated Pediatrics |
Fentanyl Dexmedetomidine Midazolam |
Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action GABA Modulators Physiological Effects of Drugs Psychotropic Drugs Anesthetics Adrenergic Agonists Sensory System Agents Therapeutic Uses Hypnotics and Sedatives Analgesics Analgesics, Opioid |
Anesthetics, Intravenous Tranquilizing Agents Adrenergic alpha-Agonists Central Nervous System Depressants Narcotics Pharmacologic Actions Adjuvants, Anesthesia Anesthetics, General Analgesics, Non-Narcotic GABA Agents Anti-Anxiety Agents Peripheral Nervous System Agents Central Nervous System Agents |