• Prescrire international · Jul 2013

    Comparative Study

    Midazolam oral transmucosal route. An alternative to rectal diazepam for some children.

    • Prescrire Int. 2013 Jul 1; 22 (140): 173-7.

    AbstractIn children, convulsive seizures lasting-more than 5 minutes constitute a life-threatening condition. Outside of the hospital setting, the treatment of choice is rectal diazepam. Midazolam, a fast-acting benzodiazepine, is now authorised for use in this setting, in the form of a solution for oral transmucosal route. The results of five trials conducted in specialised centres suggest that midazolam oromucosal solution is at least as effective as rectal diazepam in reducing the duration of seizures and preventing early seizure recurrence. However, the evidence provided by these studies is weak. The main adverse effects of midazolam oromucosal solution are the same as those of rectal diazepam; in particular, respiratory depression occurs in 1% to 5% of patients and can necessitate intubation. Some anticonvulsants, such as carbamazepine, phenytoin and phenobarbital, may reduce the effectiveness of midazolam and diazepam. At the recommended doses, midazolam overdose may occur when the oromucosal solution is used to treat infants less than 6 months old. Midazolam oromucosal solution is sold in single-dose ready-to-use oral syringes. In France, diazepam doses for rectal administration must be prepared from a vial of solution. In early 2013, the usability of oral transmucosal versus rectal administration has not been compared prospectively in children with convulsive seizures. In practice, rectal diazepam is the drug of choice for paediatric convulsive seizures occurring outside the hospital setting. Midazolam oromucosal solution is an alternative for children over 6 months of age, especially when preparation or administration of the rectal diazepam dose poses a problem.

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