Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 12:42 PM
Study NCT ID:
NCT07438834
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continuous Sedation vs Daily Sedation Interruption in Ventilated Children
Sponsor:
University of Health Sciences Lahore
Organization:
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: