Continuous Sedation vs Daily Sedation Interruption in Ventilated Children (NCT07438834) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Continuous Sedation vs Daily Sedation Interruption in Ventilated Children
96 participantsStarted 2026-03-02
Plain-language summary
Sedation is essential for mechanically ventilated pediatric patients to ensure comfort, ventilator synchrony, and prevention of self-extubation. However, excessive sedation may prolong mechanical ventilation and ICU stay, while inadequate sedation may cause agitation and physiological distress. Continuous Sedation Infusion (CSI) and Daily Sedation Interruption (DSI) are two commonly used strategies. Limited data exist comparing their impact on comfort levels in pediatric patients.
This randomized controlled trial aims to compare comfort scores between continuous Midazolam infusion and daily sedation interruption in mechanically ventilated children aged 5-10 years diagnosed with pneumonia. Comfort will be assessed using the COMFORT-B Scale and Richmond Agitation-Sedation Scale (RASS) every 6 hours for 72 hours.
The study intends to determine which strategy better maintains optimal sedation and comfort in pediatric intensive care settings.
Who can participate
Age range
5 Years – 10 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Diagnosed with pneumonia
Requiring mechanical ventilation for at least 48 hours
Requiring sedation with intravenous Midazolam
Written informed consent obtained from parent or legal guardian
Exclusion Criteria:
Pre-existing neurological impairment (e.g., traumatic brain injury, stroke, cerebral palsy) that may interfere with comfort assessment
Presence of central nervous system symptoms affecting sedation evaluation
Contraindication to Midazolam (e.g., hypersensitivity, severe hypotension, significant hepatic dysfunction)
Receiving multiple sedative agents in addition to Midazolam
Refusal of parental or guardian consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean COMFORT-B Score
Timeframe: Every 6 hours during the first 72 hours of mechanical ventilation.