Pharmacokinetics and Pharmacodynamics of Dexmedetomidine in Pediatrics Subjects

Completed · Phase 2

Conditions studied: Intubated and Mechanically Ventilated Pediatric Subjects

In brief

The objective of this study is to characterize the pharmacokinetic and pharmacodynamic profile of dexmedetomidine administered as an intravenous loading dose followed by a continuous intravenous infusion in pediatric subjects ages ≥2 through \<17 years old.

Key facts

Study ID

NCT00652028

Run by

Hospira, now a wholly owned subsidiary of Pfizer

People needed

69

Starts

2008-11-01

Expected to finish

2010-04-01

Last updated by the study team

2017-04-13

Who can join

Age: 2 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• ≥2 years old through <6 years old
• ≥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.

You may not qualify if…

• Pediatric subjects with neurological conditions that prohibit an evaluation of sedation
• Diminished consciousness from increased intracranial pressure.
• Extensive brain surgery (surgery requiring intracranial pressure monitor).
• Diminished cognitive function per PI's discretion.
• Subjects with immobility from neuromuscular disease or continuous infusion of neuromuscular blocking agents.
• Weight <10 kg.
• Subjects with second degree or third degree heart block unless subject has a pacemaker or pacing wires.
• Hepatic impairment Serum glutamic pyruvic transaminase/Alanine aminotransferase (SGPT/ALT) >100 U/L
• Hypotension based on repeat assessments prior to starting study drug:
• Age ≥2 years old through ≤12 years old: systolic blood pressure (SBP) <80 mmHg
• Age >12 years old through <17 years old: SBP <90 mmHg
• Pre-existing bradycardia prior to starting study drug defined as:
• Age ≥2 years old through ≤6 years old: ≤70 beats per minute (bpm)
• Age >6 years old through ≤12 years old: ≤60 bpm
• Age >12 years old through ≤16 years old: ≤50 bpm
• Acute thermal burns involving more than 15 percent total body surface area.
• Subjects who have a known allergy to dexmedetomidine, midazolam (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.

Where it is running

• Miami Children's Hospital — Miami, Florida, United States
• University of Louisville/Kosair Children's Hospital — Louisville, Kentucky, United States
• Women and Children's Hospital of Buffalo — Buffalo, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University Hospitals Medical Center — Cleveland, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Virginia Commonwealth University — Richmond, Virginia, United States
• Unidad Cirugia Cardiovascular de Guatemala — Guatemala City, Guatemala

Full record on ClinicalTrials.gov

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