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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 18
Healthy Volunteers: f
View:

• 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.

• Receiving IV sedation by infusion or bolus for ≤72h to aid mechanical ventilation (but will be recruited as early as possible).

Locations
Other Locations
Canada
McMaster Children's Hospital
RECRUITING
Hamilton
Children's Hospital - London Health Sciences Centre
RECRUITING
London
The Hospital for Sick Children (SickKids)
RECRUITING
Toronto
Contact Information
Primary
Sunnybrook Research Institute, Program Manager - Centre for Clinical Trials Services
ABOVETrial@sunnybrook.ca
416-480-6100
Time Frame
Start Date: 2023-10-10
Estimated Completion Date: 2026-12
Participants
Target number of participants: 60
Treatments
Experimental: Inhaled sedation - volatile anesthetic
The ICU patient will receive either Isoflurane or Sevoflurane, whichever is available at the hospital. Dosage will be modified as per health care team guidance for the best treatment of the participant.
No_intervention: IV sedation - standard of care
The ICU patient will receive standard of care, which is IV sedation supplied by the hospital. Dosage will be modified as per health care team guidance for the best treatment of the participant.
Related Therapeutic Areas
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR)
Leads: Sunnybrook Health Sciences Centre

This content was sourced from clinicaltrials.gov