Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous Sedation Infusion (CSI) | Experimental |
| |
| Daily Sedation Interruption (DSI) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Sedation Infusion (CSI) | Other | Participants receive continuous intravenous Midazolam infusion titrated according to COMFORT-B and RASS scores following PICU sedation protocol. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D012120 | Respiration Disorders |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
|