Advancing Brain Outcomes in Pediatric Critically Ill Patients Sedated With Volatile AnEsthestic Agents
Recruiting
Phase 3
Interventional Study
Intensive Care Units, Pediatric
Anesthetics, Inhalation
Mechanically Ventilated, Critically Ill Children
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 1 Month – 18
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 60 (estimated)
- Sponsor
- Sunnybrook Health Sciences Centre · Other
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About This Trial
The goal of a pilot study is to test a study plan to see if it is appropriate for a larger study. This study plan is looking at whether the use of inhaled sedatives (medications that help people be calm and sleep) can reduce delirium (extreme confusion) in children who need a ventilator (breathing machine) compared to IV or oral sedatives.
The main question\[s\] it aims to answer are:
* Will peo…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Pediatric patients age from 1 month to less than 18 years who need sedation to tolerate mechanical ventilation and will remain ventilated for ≥ 24 hours
2. Receiving IV sedation by infusion or bolus for ≤72h to aid mechanical ventilation (but will be recruited as early as pos…
Contacts
Sunnybrook Research Institute, Program Manager - Centre for Clinical Trials Services
416-480-6100
CONTACT