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NOT YET RECRUITING
NCT07438834
NA

Continuous Sedation vs Daily Sedation Interruption in Ventilated Children

Sponsor: University of Health Sciences Lahore

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

5 Years - 10 Years

Study Type

INTERVENTIONAL

Enrollment

96

Start Date

2026-03-02

Completion Date

2026-12-31

Last Updated

2026-02-27

Healthy Volunteers

No

Interventions

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.