Abstract
Purpose: To evaluate the acceptance and effectiveness of 0.2 mg·kg−1 of oral transmucosal midazolam as a premedicant in infants and preschool children.
Method: In a randomized, prospective double-blind placebo controlled study, 44 healthy children, between the ages of eight months to six years, presenting for elective surgery were divided in two groups. The medicated group received 0.2 mg·kg−1 of injectable midazolam mixed with an equal volume of strawberry syrup and the placebo group received plain syrup 0.08 ml·kg−1. Medications were placed on the anterosuperior aspect of the child’s tongue in 3–5 aliquots of 0.2–0.4 ml. A blinded observer assessed the acceptance of the medication by willingness to open the mouth for the next aliquot and the efficacy of the medication was assessed by ease of separation from the parent.
Results: Ninety-six percent of the children in the placebo group and 95% in the midazolam group willingly accepted the medication. Separation of children from parents was successful in 95% of the medicated children compared with 59% in the placebo group (P=0.006).
Conclusion: Oral midazolam in thick strawberry syrup, administered in small aliquots via the oral transmucosal route was well accepted and proved to be an effective premedicant in infants and preschool children.
Résumé
Objectif: Évaluer l’acceptation et l’efficacité de 0,2 mg·kg−1 de midazolam transmqueux administré par voie orale comme prémédication chez des bébés et de jeunes enfants.
Méthode: Ont participé à l’étude randomisée, prospective et en double aveugle contre placebo, 44 enfants en santé, de huit mois à six ans, répartis en deux groupes et qui devaient subir une intervention chirurgicale planifiée. Le groupe à l’étude a reçu 0,2 mg·kg−1 de midazolam injectable dans un volume égal de sirop de fraise. Le groupe placebo a reçu seulement 0,08 ml·kg−1 de sirop. Le médicament a été déposé sur la face antérosupérieure de la langue de l’enfant en 3–5 parties égales de 0,2–0,4 ml. Un observateur impartial a évalué l’acceptation du médicament par la bonne volonté à ouvrir la bouche pour recevoir une autre dose. L’efficacité a été mesurée par la facilité de l’enfant à se séparer de ses parents.
Résultats: Le médicament a été facilement accepté par 96% des enfants du groupe placebo et 95% du groupe midazolam. La séparation des enfants d’avec leurs parents s’est bien passée chez 95% des enfants médicamentés et chez 59% des enfants du groupe placebo (P=0,006).
Conclusion: Le midazolam administré par voie orale et en petites doses égales dans un sirop de fraise a été bien accepté et a été efficace chez des bébés et de jeunes enfants.
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Pandit, U.A., Collier, P.J., Malviya, S. et al. Oral transmucosal midazolam premedication for preschool children. Can J Anaesth 48, 191–195 (2001). https://doi.org/10.1007/BF03019734
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DOI: https://doi.org/10.1007/BF03019734