Trial reportIndian journal of pediatrics2025
Sedative and Analgesic Drug Rotation Protocol Versus Non-Rotation Protocol in Mechanically Ventilated Children: A Randomised Controlled Trial.
Trial report in Indian journal of pediatrics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
objectivesTo compare the proportion of children with withdrawal syndrome in sedoanalgesic drug rotation protocol vs. sedoanalgesia with no rotation using Withdrawal Assessment Tool Version-1 (WAT-1).
methodsSixty children one mo to 18 y admitted to the Pediatric Intensive Care Unit (PICU) for mechanical ventilation were randomized into two groups in a 1:1 ratio. The intervention group received a protocolized rotation of sedative and analgesic drugs combination. In contrast, the control group received sedative and analgesic drugs without any rotation for the entire duration of ventilation. In both groups, adequate depth of sedation was achieved by titrating the sedatives using COMFORT-Behavioural (COMFORT-B) scores. The primary outcome assessed was the incidence of withdrawal syndrome as defined by a WAT-1 score ≥ 3. Secondary outcomes included cumulative doses of midazolam needed as rescue therapy, mechanical ventilation (MV) duration, need for inotropic support, and the length of stay (LOS) in the PICU.
resultsIn the present study, median (IQR) age of patients was 24 (7, 93) mo. There was a reduced incidence (20% vs. 53.3%; P = 0.004) and median duration of withdrawal syndrome (WAT-1 score ≥ 3) [1 (IQR 0, 2) vs. 0 (IQR 0, 0); P = 0.012] in the intervention group compared to the control group. The need for inotropic support was higher in the intervention group (62.5% vs. 37.5%; P = 0.038). No other statistically significant outcomes were seen.
conclusionsThe present study showed that protocolised rotation of sedoanalgesic drugs in mechanically ventilated children can result in lower incidence as well as the duration of withdrawal syndrome.
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