Oral transmucosal midazolam premedication for preschool children

Abstract

To evaluate the acceptance and effectiveness of 0.2 mg x kg(-1) of oral transmucosal midazolam as a premedicant in infants and preschool children. 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 x kg(-1) of injectable midazolam mixed with an equal volume of strawberry syrup and the placebo group received plain syrup 0.08 ml x 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. 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). 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.