Continuous Sedation vs Daily Sedation Interruption in Ventilated Children

NCT07438834 | Not Yet Recruiting

• 1 other identifier: Exp135
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Mean COMFORT-B Score

  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.

  Every 6 hours during the first 72 hours of mechanical ventilation.

Study Arms (2)

Continuous Sedation Infusion (CSI)

EXPERIMENTAL

Other: Continuous Sedation Infusion (CSI)

Daily Sedation Interruption (DSI)

EXPERIMENTAL

Other: Daily Sedation Interruption (DSI)

Interventions

Continuous Sedation Infusion (CSI) OTHER

Participants receive continuous intravenous Midazolam infusion titrated according to COMFORT-B and RASS scores following PICU sedation protocol.

Continuous Sedation Infusion (CSI)

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.

Daily Sedation Interruption (DSI)

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• University of Health Sciences Lahore: lead

MeSH Terms

Conditions

Pneumonia; Respiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: February 22, 2026
• First Posted: February 27, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02