What is this study trying to find out about sedation in mechanically ventilated children?

This study is evaluating whether inhaled sedatives can reduce delirium compared to standard intravenous sedation in children who need mechanical ventilation. It is also assessing if the study plan is feasible and accepted by healthcare teams. The research is sponsored by Sunnybrook Health Sciences Centre and aims to improve sedation methods in pediatric intensive care.

Who may be eligible for this pediatric intensive care clinical trial?

Children from 1 month up to 18 years old who need sedation to tolerate mechanical ventilation for at least 24 hours and are currently receiving IV sedation may be eligible. There are no gender restrictions. Certain medical conditions and treatments, such as a history of malignant hyperthermia or use of specific inhaled medications, may exclude participation. Please review eligibility criteria for more details.

Is there any cost to participate in this pediatric sedation clinical trial?

Study-related care, including the sedative medications and all trial visits, is provided at no cost. However, personal travel expenses and other costs may vary and are not guaranteed to be covered. Participants and families should consider these factors when joining the trial.

Actively Recruiting

Phase 3

Age: 1Month - 18Years

All Genders

ID05867472

Pilot Trial Comparing Inhaled Isoflurane Sedation Versus Standard Intravenous Sedation in Mechanically Ventilated Children in Pediatric Intensive Care

Led by Sunnybrook Health Sciences Centre · Updated on 2026-02-04

Participants Needed

Research Sites

30 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are conducting a pilot study to evaluate if inhaled sedatives can reduce delirium, a state of extreme confusion, in children on mechanical ventilators compared to the usual intravenous IV sedatives. This study aims to assess the feasibility of the study plan, including recruitment, participant completion, and healthcare team acceptance. The trial focuses on pediatric patients who require sedation for mechanical ventilation and is designed as a randomized controlled trial. Participants will be randomly assigned to receive either inhaled sedation with Isoflurane delivered through an inhalation device or standard IV sedation provided by hospital care. Dosages for both sedatives will be adjusted by the healthcare team to best support the participants treatment needs. Participants will be monitored daily for up to 28 days during their ventilation period. Throughout the study, participants will undergo assessments of memory, thinking, and behavior 9 to 12 months after treatment. Researchers will also track recruitment rates, adherence to the study protocol, participant dropout rates over three years, safety and adverse events for up to 13 months, and healthcare team satisfaction in the first three days. The study is expected to complete by December 2026.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 1Month - 18Years

All Genders

Eligibility Criteria

You may qualify if you...

Pediatric patients aged from 1 month to less than 18 years who require sedation to tolerate mechanical ventilation and are expected to remain ventilated for 24 hours or more
Receiving intravenous sedation by infusion or bolus for 72 hours or less to aid mechanical ventilation
Recruitment will occur as early as possible during sedation

You will not qualify if you...

Current use of inhaled prostacyclin or continuous salbutamol nebulization
Family or personal history of malignant hyperthermia
Allergy to isoflurane, sevoflurane, or other volatile inhaled anesthetic gases
Metabolic, mitochondrial, or myopathy diseases such as Duchenne muscular dystrophy
Moribund condition with expected survival less than 24 hours
Known pregnancy or lactation
Suspected or evidence of high intracranial pressure
Not using a closed ventilator circuit due to potential gas leaks
Prior enrollment in this trial

Research Team

Sunnybrook Research Institute, Program Manager - Centre for Clinical Trials Services

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