Pharmacokinetics and Pharmacodynamics of Dexmedetomidine in Pediatrics Subjects
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Purpose
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: Dexmedetomidine, midazolam; fentanyl |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- Assessment of pharmacokinetics and pharmacodynamics of dexmedetomidine [ Time Frame: Over 24 hour period ] [ Designated as safety issue: Yes ]
| Enrollment: | 59 |
| Study Start Date: | August 2008 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Group 1
Dose level 1
|
Drug: Dexmedetomidine, midazolam; fentanyl
Dexmedetomidine for sedation; midazolam for rescue sedation according to label; fentanyl for rescue pain according to the label
|
|
Group 2
Dose level 2
|
Drug: Dexmedetomidine, midazolam; fentanyl
Dexmedetomidine for sedation; midazolam for rescue sedation according to label; fentanyl for rescue pain according to the label
|
|
Group 3
Dose level 3
|
Drug: Dexmedetomidine, midazolam; fentanyl
Dexmedetomidine for sedation; midazolam for rescue sedation according to label; fentanyl for rescue pain according to the label
|
|
Group 4
Dose level 4
|
Drug: Dexmedetomidine, midazolam; fentanyl
Dexmedetomidine for sedation; midazolam for rescue sedation according to label; fentanyl for rescue pain according to the label
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 2 Years to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Initially intubated and mechanically ventilated pediatric subjects in an intensive care setting anticipated to require a minimum of 6 hours of continuous intravenous sedation.
Age: subjects must fit into one of the following age ranges at screening:
- > or equal to 2 years old through < 6 years old
- > or equal to 6 years old through < 17 years old
If female, subject is non-lactating and is either:
- Not of childbearing potential, defined as pre-menarche, or surgically sterile due to bilateral tubal ligation, bilateral oophorectomy or hysterectomy.
- Of childbearing potential but is not pregnant at time of baseline.
- Subject's parent(s) or legal guardian(s) has/have voluntarily signed and dated the informed consent document approved by the Institutional Review Board. Assent will be obtained where age-appropriate and according to state regulations.
Exclusion Criteria:
- Pediatric subjects with neurological conditions that prohibit an evaluation of sedation
- Weight < 10 kg.
- Subjects with second degree or third degree heart block unless subject has a pacemaker or pacing wires.
- Hepatic impairment SGPT/ALT >100 U/L
- Hypotension based on repeat assessments
- Pre-existing bradycardia
- Acute thermal burns involving more than 15 percent total body surface area.
- Subjects who have a known allergy to dexmedetomidine, MDZ or fentanyl.
- Subjects with a life expectancy that is < 72 hours.
- Subjects that are expected to have hemodialysis (continuous hemofiltration) or peritoneal dialysis within 48 hours.
- Subjects who have been treated with α-2 agonists/antagonists within two weeks.
- Subjects with a spinal cord injury above T5.
- Subjects who have received another investigational drug within the past 30 days.
- Subjects on nicotine replacement therapy.
- Subjects who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of this clinical study.
Contacts and Locations| United States, Florida | |
| Variety Children's Hospital/Miami Children's Hospital | |
| Miami, Florida, United States, 33155 | |
| United States, Kentucky | |
| University of Louisville/Kosair Children's Hospital | |
| Louisville, Kentucky, United States, 40202 | |
| United States, New York | |
| Children's Hospital of Buffalo | |
| Buffalo, New York, United States, 14222 | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Rainbow Babies and Children's Hospital | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Children's Hospital of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Virginia | |
| Virginia Commonwealth University | |
| Richmond, Virginia, United States, 23219 | |
| Guatemala | |
| Unidad Cirugia Cardiovascular de Guatemala | |
| Guatemala City, Guatemala | |
More Information
No publications provided
| Responsible Party: | Hospira, Inc. |
| ClinicalTrials.gov Identifier: | NCT00652028 History of Changes |
| Other Study ID Numbers: | DEX-08-01 |
| Study First Received: | April 1, 2008 |
| Last Updated: | September 6, 2011 |
| Health Authority: | United States: Food and Drug Administration Guatemala: Ministry of Public Health and Social Assistance |
Keywords provided by Hospira, Inc.:
|
Pharmacokinetics Pharmacodynamics Escalating dose Dexmedotimidine |
Intubated Mechanically ventilated Pediatrics |
Additional relevant MeSH terms:
|
Midazolam Fentanyl Dexmedetomidine Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Psychotropic Drugs Hypnotics and Sedatives Anesthetics, Intravenous Anesthetics, General |
Anesthetics GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Narcotics Analgesics Sensory System Agents Peripheral Nervous System Agents Analgesics, Opioid Analgesics, Non-Narcotic Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents |
ClinicalTrials.gov processed this record on May 19, 2013