Sedation Management in Pediatric Patients Supported on Mechanical Ventilation
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Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this two-year project is to pilot test an intervention to change sedation management in pediatric patients supported on mechanical ventilation for acute respiratory failure in the pediatric intensive care unit (PICU). While ensuring patient comfort is an integral part of pediatric critical care, analgesic and sedative use in this patient population is associated with injury; specifically, comfort medications may depress spontaneous ventilation and prolong the duration of mechanical ventilation. Additionally, drug tolerance develops over time and may precipitate iatrogenic abstinence syndrome (chemical withdrawal) when the patient no longer requires sedation. Alternatively, suboptimal comfort management contributes to the patient not breathing synchronously with the ventilator and/or self-removal of breathing tubes. Our group has developed and validated a nurse-implemented sedation algorithm (set of specific instructions) to guide titration of comfort medications that may optimize patient comfort and reduce the risk of under-medication, but this algorithm needs to be evaluated further. We hypothesize that pediatric patients managed per sedation protocol will experience fewer days of mechanical ventilation than patients receiving usual care. This research has the potential of revolutionizing sedation practices that are driven by and synchronized to patient needs.
Study identification
- NCT ID
- NCT00142766
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- NIH
- Enrollment
- 245 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 2 Weeks to 18 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
- Feb 2004 (Type not available)
- Primary completion
- Jul 2006 (Actual)
- Completion
- Mar 2007 (Actual)
- Last update posted
- Oct 7, 2015
2004 – 2007
United States locations
- U.S. sites
- 3
- U.S. states
- 3
- U.S. cities
- 3
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | — |
| Children's Hospital Boston | Boston | Massachusetts | 02115 | — |
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53201 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00142766, 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 Oct 7, 2015 · Synced Nov 14, 2026
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