3% saline versus mannitol in the treatment of cerebral edema in children: a randomized controlled trial

Vollständiger Abstract

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Background: Cerebral edema with raised intracranial pressure is a pediatric neurological emergency associated with coma, herniation and death. Mannitol and hypertonic saline are commonly used osmotic agents, but comparative pediatric data remain limited and heterogeneous. To compare the efficacy and safety of 3% hypertonic saline with 20% mannitol in children aged 3 months to 12 years with cerebral edema. Methods: This randomized controlled trial was conducted from 2023 to 2025 among 70 children with clinical or radiological evidence of cerebral edema. Eligible children were randomized equally into the mannitol group (n=35) and 3% saline group (n=35). Mannitol was administered as 20% mannitol at 1.5 ml/kg intravenously over 20 minutes every 8 hours, whereas 3% saline was administered at 5 ml/kg intravenously over 20 minutes every 8 hours. Other supportive management was standardized. Outcomes included early Glasgow Coma Scale improvement, time to recovery from coma, duration of ventilation, survival and treatment-related complications. Results: Baseline age, sex, nutritional status, admission GCS, etiology and diagnostic features were comparable between groups. Early GCS improvement of at least 2 points within 6 hours occurred in 23 children (65.7%) in the 3% saline group compared with 13 children (37.1%) in the mannitol group (p=0.031). Coma duration ≤24 hours was observed in 18 children (51.4%) receiving 3% saline and 9 children (25.7%) receiving mannitol (p=0.026). Ventilation duration ≤24 hours was more frequent with 3% saline (14 (40.0%)) than mannitol (6 (17.1%)) (p=0.034). Survival was higher in the 3% saline group (32 (91.4%)) than in the mannitol group (26 (74.3%)), but this difference was not statistically significant (p=0.110). Hypernatremia was more frequent with 3% saline (9 (25.7%) vs 2 (5.7%); p=0.045), while renal dysfunction was numerically more frequent with mannitol (5 (14.3%) vs 1 (2.9%); p=0.198). Conclusions: In children with cerebral edema, 3% hypertonic saline was associated with faster early neurological improvement and shorter coma and ventilation duration compared with mannitol, while mortality difference was not statistically significant. Hypernatremia requires close monitoring during hypertonic saline therapy.