NCT07438834

Continuous Sedation vs Daily Sedation Interruption in Ventilated Children

Comparison of Comfort Scores Between Continuous Midazolam Infusion and Daily Sedation Interruption in Mechanically Ventilated Pediatric Patients With Pneumonia: A Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: University of Health Sciences Lahore · Academic / Other
• Sex: All
• Age: 5 Years – 10 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pneumonia
• Respiration Disorders

Interventions

Type	Name	Description
OTHER	Continuous Sedation Infusion (CSI)	Participants receive continuous intravenous Midazolam infusion titrated according to COMFORT-B and RASS scores following PICU sedation protocol.
OTHER	Daily Sedation Interruption (DSI)	Participants receive Midazolam infusion with daily interruption for 1-2 hours to assess neurological function and comfort level. Sedation is restarted if needed and titrated according to scoring scales.

Timeline

• Start date: 2026-03-02
• Primary completion: 2026-12-30
• Completion: 2026-12-31
• First posted: 2026-02-27
• Last updated: 2026-02-27