Phase 3 Completed N=175 Randomized Quadruple-blind Treatment

Study Evaluating Safety and Efficacy of Dexmedetomidine (DEX) in Intubated and Mechanically Ventilated Pediatric Intensive Care Unit (PICU) Subjects

Sedation

Source: ClinicalTrials.gov NCT00875550 ↗

Enrolled (actual)

175

Serious AEs

1.1%

Results posted

Oct 2014

Primary outcomePrimary: 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

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

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	—

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).

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.