Study Evaluating Safety and Efficacy of Dexmedetomidine (DEX) in Intubated and Mechanically Ventilated Pediatric Intensive Care Unit (PICU) Subjects
Public ClinicalTrials.gov record NCT00875550. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III Randomized, Double-blind, Dose-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Dexmedetomidine in Intubated and Mechanically Ventilated Pediatric Intensive Care Unit Subjects
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT00875550
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 175 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 1 Month to 16 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 2009
- Primary completion
- Dec 31, 2010
- Completion
- Dec 31, 2010
- Last update posted
- Aug 13, 2015
2010 – 2011
United States locations
- U.S. sites
- 33
- U.S. states
- 19
- U.S. cities
- 30
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Maricopa Medical Center | Phoenix | Arizona | 85008 | — |
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202 | — |
| Loma Linda University Medical Center, Pediatric Dept., Div. of Critical Care - PICU | Loma Linda | California | 92354 | — |
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | — |
| Pediatric Critical Care | Los Angeles | California | 90095 | — |
| Dept. of Anesthesia, SUMC | Stanford | California | 94305 | — |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | — |
| Joe Dimaggio Children's Hospital/Memorial Regional Hospital, Pediatric Intensive Care Unit | Hollywood | Florida | 33021 | — |
| Critical Care | Jacksonville | Florida | 32207 | — |
| University of Miami - Miller School of Medicine | Miami | Florida | 33136 | — |
| Miami Children's Hospital | Miami | Florida | 33155 | — |
| Not listed | Orlando | Florida | 32806 | — |
| Pensacola Research Consultants, Inc. | Pensacola | Florida | 32504 | — |
| University of Chicago Comer Children's Hospital | Chicago | Illinois | 60637 | — |
| Loyola University Medical Center | Maywood | Illinois | 60153 | — |
| Advocate Lutheran General Children's Hospital | Park Ridge | Illinois | 60068 | — |
| Kosair Charities Pediatric Clinical Research Unit, University of Louisville | Louisville | Kentucky | 40202 | — |
| The John Hopkins Medical Institutions, Anesthesia and Critical Care Medicine | Baltimore | Maryland | 21287-8711 | — |
| F3900 C.S. Mott Hospital SPC 5211 Dept. of Anaesthesiology | Ann Arbor | Michigan | 48109-5211 | — |
| Children's Hospital of Michigan | Detroit | Michigan | 48201 | — |
| Gilette Children's Speciality Healthcare | Saint Paul | Minnesota | 55101 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| Duke University Medical Center, Department of Anesthesiology | Durham | North Carolina | 27710 | — |
| Akron Children's Hospital Medical Center | Akron | Ohio | 44308 | — |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | — |
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | — |
| Northwest Pediatric Critical Care, P.C. Legacy Emanuel Children's Hospital | Portland | Oregon | 97227 | — |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | — |
| Medical University of South Carolina (MUSC) | Charleston | South Carolina | 29425 | — |
| Children's Medical Center Dallas | Dallas | Texas | 75235 | — |
| University of Virginia, Division of Pediatric Critical Care | Charlottesville | Virginia | 22908 | — |
| Virginia Commonwealth University | Richmond | Virginia | 23298-0530 | — |
| Not listed | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00875550, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 13, 2015 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00875550 live on ClinicalTrials.gov.