Phase 3
N=175
Study Evaluating Safety and Efficacy of Dexmedetomidine (DEX) in Intubated and Mechanically Ventilated Pediatric Intensive Care Unit (PICU) Subjects
Sedation
Bottom Line
View on ClinicalTrials.gov: NCT00875550 ↗Enrolled (actual)
175
Serious AEs
1.1%
Results posted
Oct 2014
Primary outcome: Primary: Percentage of Subjects That do Not Require Rescue Midazolam (MDZ) for Sedation Based on Achieving and Maintaining a Target University of Michigan Sedation Scale (UMSS) Score of 1 to 3 While Intubated. — 44.6; 54.3 Percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dexmedetomidine (Drug); Midazolam (Drug); Fentanyl (Drug); Morphine (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects That do Not Require Rescue Midazolam (MDZ) for Sedation Based on Achieving and Maintaining a Target University of Michigan Sedation Scale (UMSS) Score of 1 to 3 While Intubated. |
44.6; 54.3 | — |
| SECONDARY Absolute Time on Study Drug That the Subject is in a UMSS Range of 1 to 3 While Intubated |
17.2; 17.3 | — |
| SECONDARY Absolute Time on Study Drug That the Subject is Out of the Target Sedation Range (UMSS <1 or >3) While Intubated |
1.0; 0.7 | — |
| SECONDARY Total Amount of Rescue Medication Required for Sedation and Analgesia While Intubated |
2.221; 1.241; 45.225; 44.367; 1.446; 1.141 | — |
| SECONDARY Time to First Dose of Rescue Medication for Sedation and Analgesia |
1.6; 2.0 | — |
| SECONDARY Time to Successful Extubation |
23.8; 20.5 | — |
Summary
The purpose of this study is to evaluate the safety and efficacy of dexmedetomidine (DEX) in intubated and mechanically ventilated pediatric intensive care unit (PICU) subjects. The key study objectives are:
* To characterize the loading and maintenance dosing of DEX by age group and overall medical condition of pediatric subjects
* To evaluate the safety and efficacy of loading and maintenance infusions for sedation in initially intubated and mechanically ventilated PICU subjects
* To explore the exposure-response relationship between dose of DEX and clinical measures of sedation and safety
Eligibility Criteria
Inclusion Criteria
- Initially intubated and mechanically ventilated pediatric subjects (≥1 month [birth age corrected for prematurity] to 6 months to 2 to 12 to 165 U/L; >12 months to 2 vasopressors).
- Subjects who will require alpha-2 agonists/antagonists listed below within 48 hrs prior to baseline.
Alpha-2 Agonists: Xylazine*, Clonidine (Catapres, Dixarit), Guanfacine (Tenex), Guanabenz (Wytensin), Mivazerol, Guanadrel (Hylorel), Guanethidine (Ismelin) and Methyldopa (Aldomet). * Xylazine is a veterinary product, but has abuse potentIal in humans.
Alpha-2 Antagonists: Corynanthine, Phenoxybenzamine (Dibenzyline), Phentolamine (Regitine, Rogitine), Tolazoline (Priscoline), Yohimbine, Rauwolscine, Idazoxan, Reserpine (Serpasil) and Mirtazapine (Remeron, Remeron Soltab).
Data sourced from ClinicalTrials.gov (NCT00875550). 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.