Status:
COMPLETED
Pharmacokinetics and Pharmacodynamics of Dexmedetomidine in Pediatrics Subjects
Lead Sponsor:
Hospira, now a wholly owned subsidiary of Pfizer
Conditions:
Intubated and Mechanically Ventilated Pediatric Subjects
Eligibility:
All Genders
2-16 years
Phase:
PHASE2
Brief 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 infus...
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 initi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT00652028
Start Date
November 1 2008
End Date
April 1 2010
Last Update
April 13 2017
Active Locations (9)
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1
Miami Children's Hospital
Miami, Florida, United States, 33155
2
University of Louisville/Kosair Children's Hospital
Louisville, Kentucky, United States, 40202
3
Women and Children's Hospital of Buffalo
Buffalo, New York, United States, 14222
4
Duke University Medical Center
Durham, North Carolina, United States, 27710