Phase 2
N=59
Pharmacokinetics and Pharmacodynamics of Dexmedetomidine in Pediatrics Subjects
Intubated and Mechanically Ventilated Pediatric Subjects
Bottom Line
View on ClinicalTrials.gov: NCT00652028 ↗Enrolled (actual)
59
Serious AEs
1.7%
Results posted
Aug 2015
Primary outcome: Primary: Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measurable Concentration (AUC0-t) — 2681.332; 6460.576; 16992.540; 28531.864 picograms*hr/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Dexmedetomidine, midazolam; fentanyl (Drug)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measurable Concentration (AUC0-t) |
2681.332; 6460.576; 16992.540; 28531.864 | — |
| PRIMARY Area Under the Concentration-time Curve From Time Zero to the Time Infinity (AUC0-∞) |
3153.518; 6673.163; 17300.539; 28970.541 | — |
| PRIMARY Observed Peak Plasma Concentration |
480.437; 847.691; 3385.569; 3090.939 | — |
| PRIMARY Terminal Elimination Half-life (t1/2) |
1.546; 1.743; 2.045; 2.145 | — |
| PRIMARY Plasma Concentration at Steady State (Css) |
402.026; 539.848; 1347.284; 2827.144 | — |
| PRIMARY Volume of Steady State Distribution (Vss) |
56.808; 35.246; 32.789; 43.652 | — |
| PRIMARY Clearance (CL) |
32.208; 20.268; 18.565; 22.199 | — |
| PRIMARY Level of Sedation Based on Average Ramsay Sedation Scale (RSS) Score |
2.4; 2.8; 2.4; 4.0 | — |
| PRIMARY Number of Subjects Who Received Rescue Medication for Sedation (Midazolam) and Analgesics (Fentanyl) |
7; 7; 5; 3; 12; 10 | — |
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.
Eligibility 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 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) 12 years old through 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.
Data sourced from ClinicalTrials.gov (NCT00652028). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.