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RECRUITING
NCT05867472
PHASE3

Advancing Brain Outcomes in Pediatric Critically Ill Patients Sedated With Volatile AnEsthestic Agents

Sponsor: Sunnybrook Health Sciences Centre

View on ClinicalTrials.gov

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.

Official title: Advancing Brain Outcomes in Pediatric Critically Ill Patients Sedated With Volatile AnEsthestic Agents: A Pilot Multicentre Randomized Controlled Trial

Key Details

Gender

All

Age Range

1 Month - 18 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2023-10-10

Completion Date

2026-12

Last Updated

2026-02-04

Healthy Volunteers

No

Interventions

DRUG

Isoflurane Inhalant Product

Isoflurane will be administered using an inhalation device

Locations (3)

McMaster Children's Hospital

Hamilton, Ontario, Canada

Children's Hospital - London Health Sciences Centre

London, Ontario, Canada

The Hospital for Sick Children (SickKids)

Toronto, Ontario, Canada