Continuous Sedation vs Daily Sedation Interruption in Ventilated Children
Starting soon · Not applicable
Conditions studied: Pneumonia, Respiration Disorders
In brief
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.
Key facts
- Study ID
- NCT07438834
- Run by
- University of Health Sciences Lahore
- People needed
- 96
- Starts
- 2026-03-02
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-02-27
Who can join
Age: 5 and older, up to 10. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Full record on ClinicalTrials.gov
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