Pharmacokinetics and Pharmacodynamics of Dexmedetomidine in Pediatrics Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospira, Inc.
ClinicalTrials.gov Identifier:
NCT00652028
First received: April 1, 2008
Last updated: September 6, 2011
Last verified: September 2011

April 1, 2008
September 6, 2011
August 2008
April 2010   (final data collection date for primary outcome measure)
Assessment of pharmacokinetics and pharmacodynamics of dexmedetomidine [ Time Frame: Over 24 hour period ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00652028 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Pharmacokinetics and Pharmacodynamics of Dexmedetomidine in Pediatrics Subjects
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

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Intubated and Mechanically Ventilated Pediatric Subjects
Drug: Dexmedetomidine, midazolam; fentanyl
Dexmedetomidine for sedation; midazolam for rescue sedation according to label; fentanyl for rescue pain according to the label
  • Group 1
    Dose level 1
    Intervention: Drug: Dexmedetomidine, midazolam; fentanyl
  • Group 2
    Dose level 2
    Intervention: Drug: Dexmedetomidine, midazolam; fentanyl
  • Group 3
    Dose level 3
    Intervention: Drug: Dexmedetomidine, midazolam; fentanyl
  • Group 4
    Dose level 4
    Intervention: Drug: Dexmedetomidine, midazolam; fentanyl
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
59
August 2010
April 2010   (final data collection date for primary outcome measure)

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:

    1. Not of childbearing potential, defined as pre-menarche, or surgically sterile due to bilateral tubal ligation, bilateral oophorectomy or hysterectomy.
    2. 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.
Both
2 Years to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Guatemala
 
NCT00652028
DEX-08-01
Yes
Hospira, Inc.
Hospira, Inc.
Not Provided
Not Provided
Hospira, Inc.
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP