Pharmacokinetics and Pharmacodynamics of Dexmedetomidine in Pediatrics Subjects

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospira, Inc.; Hospira, now a wholly owned subsidiary of Pfizer
• Treatments: Dexmedetomidine; Fentanyl; Midazolam

Criteria

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:

• ≥2 years old through <6 years old

• ≥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

• 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.