Protocolized Sedation Utilizing COMFORT-B Scale versus Non-protocol-directed Sedation in Mechanically Ventilated Children - An Open-label, Randomized Controlled Trial

This study aimed to determine the effect of protocolized sedation using the COMFORT-B scale on the duration of mechanical ventilation (DMV). Eighty children with anticipated Duration of mechanical ventilation (DMV) >24 h admitted to the Pediatric intensive care unit (PICU) were randomized into one group that received protocolized sedation (PS) using the COMFORT behavioural (COMFORT-B) scale, and another group that received non-protocolized sedation (NPS). The primary outcome was the impact on the DMV. The DMV was significantly lower in PS (PS: 3.5 [3-7] vs. NPS group: 8.5 [4.25-13.75] d; p = 0.008). The cumulative dose and duration of fentanyl in the PS group was significantly lower (median [IQR]; 120 [62.88-279.12] vs. 320.4 [110.88-851.52] mu g/kg; p = 0.007 and 4 [2.25-7.75] vs. 8 [4-17.5] d; p = 0.009, respectively). The authors found a decrease in DMV and sedation related adverse events (SRAE) like ventilator associated pneumonia (VAP), accidental extubation, post-extubation stridor and dose and duration of sedative agents with PS.