Trials / Recruiting
RecruitingNCT05867472
Advancing Brain Outcomes in Pediatric Critically Ill Patients Sedated With Volatile AnEsthestic Agents
Advancing Brain Outcomes in Pediatric Critically Ill Patients Sedated With Volatile AnEsthestic Agents: A Pilot Multicentre Randomized Controlled Trial
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Sunnybrook Health Sciences Centre · Academic / Other
- Sex
- All
- Age
- 1 Month – 18 Years
- Healthy volunteers
- Not accepted
Summary
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 people join the study? (recruitment) * Will participants finish the study? * Will healthcare teams accept the study procedures? Participants will be randomized to receive study treatment (inhaled sedation) or standard of care (IV sedation). They will be monitored daily for up to 28 days. They will complete memory, thinking and behaviour tasks after 9-12 months.
Conditions
- Intensive Care Units, Pediatric
- Anesthetics, Inhalation
- Mechanically Ventilated, Critically Ill Children
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Isoflurane Inhalant Product | Isoflurane will be administered using an inhalation device |
Timeline
- Start date
- 2023-10-10
- Primary completion
- 2026-05-01
- Completion
- 2026-12-01
- First posted
- 2023-05-22
- Last updated
- 2026-02-04
Locations
3 sites across 1 country: Canada
Source: ClinicalTrials.gov record NCT05867472. Inclusion in this directory is not an endorsement.