Continuous Sedation vs Daily Sedation Interruption in Ventilated Children

Sponsor
University of Health Sciences Lahore
Study ID
NCT07438834
Status
Not Yet Recruiting

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Conditions

  • Pneumonia
  • Respiration Disorders

Eligibility Criteria

Sex
ALL
Age
5 Years - 10 Years
Healthy Volunteers
Not accepted

Interventions

  • Continuous Sedation Infusion (CSI) — OTHER
    Participants receive continuous intravenous Midazolam infusion titrated according to COMFORT-B and RASS scores following PICU sedation protocol.
  • Daily Sedation Interruption (DSI) — OTHER
    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.

Study Details

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 Dates

First listed
Feb 27, 2026
Start date
Mar 2, 2026
Status verified
Feb 2026
Primary completion
Dec 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
96 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Continuous Sedation Infusion (CSI)
  • Experimental: Daily Sedation Interruption (DSI)

Primary Outcome Measure

Mean COMFORT-B Score [ Time Frame: Every 6 hours during the first 72 hours of mechanical ventilation. ]

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