Continuous Sedation vs Daily Sedation Interruption in Ventilated Children
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-10
SponsorUniversity of Health Sciences Lahore
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Continuous Sedation Infusion (CSI)
Other interventionParticipants receive continuous intravenous Midazolam infusion titrated according to COMFORT-B and RASS scores following PICU sedation protocol.
Daily Sedation Interruption (DSI)
Other interventionParticipants 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.
Treatment groups
96 Participants
are divided into 2 treatment groupsGroup A: Continuous Sedation Infusion (CSI)Experimental treatment 1 intervention
Group B: Daily Sedation Interruption (DSI)Experimental treatment 1 intervention
Trial outcomes
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.
Time frame
Every 6 hours during the first 72 hours of mechanical ventilation.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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