Pneumonia, Respiration Disorders
Conditions
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.
Interventions
OTHERContinuous Sedation Infusion (CSI)
Participants receive continuous intravenous Midazolam infusion titrated according to COMFORT-B and RASS scores following PICU sedation protocol.
OTHERDaily 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.
Sponsors
University of Health Sciences Lahore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 10 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean COMFORT-B Score | 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. |
Outcome results
None listed