Continuous Sedation vs Daily Sedation Interruption in Ventilated Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Continuous Sedation Infusion (CSI), Daily Sedation Interruption (DSI).
- Who it may be relevant to
- Registry conditions: Pneumonia, Respiration Disorders. Basic parameters: 5 years — 10 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
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.
Primary outcome measures
- Mean COMFORT-B Score [Time frame: Every 6 hours during the first 72 hours of mechanical ventilation.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07438834 · Exp135