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

NCT00875550 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2015-08-14

Study results available
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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

Conditions

  • Sedation

Interventions

DRUG

Dexmedetomidine

Study drug titrated up or down to maintain target UMSS range.

DRUG

Midazolam

Rescue medication for sedation according to UMSS scores

DRUG

Fentanyl

Rescue medication for pain based on UMSS scores

DRUG

Morphine

Rescue medication for pain based on UMSS scores.

Sponsors & Collaborators

  • Hospira, now a wholly owned subsidiary of Pfizer

    lead INDUSTRY

Principal Investigators

  • Robert Bilkovski, MD · Medical Director, Hospira

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00875550 on ClinicalTrials.gov