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NCT Number: NCT07438834

Continuous Sedation vs Daily Sedation Interruption in Ventilated Children

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.

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Key information

Conditions

Pneumonia Infections Lung Diseases Respiration Disorders Respiratory Tract Diseases Respiratory Tract Infections

Age range

5 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Mean COMFORT-B Score

    Time frame: Every 6 hours during the first 72 hours of mechanical ventilation.

    Measurement of patient comfort using the COMFORT-B Scale. Scores range from 6 to 30, with 11-22 indicating optimal sedation. Mean scores will be compared between the two intervention groups.

Sponsors and collaborators

Lead sponsor

University of Health Sciences Lahore

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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