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소아 환자에서 미다졸람의 경구 투여와 근육 투여에의한 진정 효과의 비교 연구

The comparative study on the sedative effect of oral midazolam and intramuscular midazolam in sedatingyoung pediatric dental patients

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초록

미다졸람은 소아 환자의 진정시 흔히 사용되는 약물로서 안전성이 뛰어나고 사용이 편리하며 투여 방법이 다양하다. 여러 투여 방법 중, 주로 사용되는 근육내 투여 방법은 동통을 유발하기 때문에 어린이의 치과에 대한 공포를 가중시킬 수 있다. 따라서 근육내 투여의 이런 단점을 완화할 수 있도록 용량에 따른 미다졸람 경구 투여의 진정 효과를 근육내 투여시의 진정 효과와 비교 평가하고자 하였다. 총 12명의 환자를 실험대상으로 하였으며 이중 맹검법에 의해 두 번의 내원중 임의로 한 번은 Midazolam 0.75㎎/㎏을 경구 투여하고, 한 번은 미다졸람 0.3㎎/㎏을 근육내 투여하여 치료하였으며, 치료과정 동안 환자의 생징후(말초 동맥혈 산소 포화도, 심박수)와 행동양상을 Ohio State University Behavior rating scale과 Automated Counting System을 사용하여 평가하였다. 생징후의 경우 양 군 모두 정상범위 내에서 안정된 양상을 보였으며, 임상적으로 바람직한 행동양상(Q:Quiet)의 비율이 양 군에서 대부분 높게 나타났으며 양 군간에 유의한 차이를 보이지 않았다.(p>0.05) 본 연구에서 미다졸람을 근육내 투여한 군과 경구 투여한 군 모두 진정 효과가 양호한 결과를 보였으며 양 군간에 유의한 차이를 보이지 않았다(p>0.05).

Abstract

When routine behavior control is impossible, midazolam is often used for sedation, because it has wide margin of safety, relatively few side-effects and multiple route of administration. Although intramuscular administration of all administration route is frequently used, it is a major source of anxiety, discomfort, and trauma in children. To the contrary, oral administration of midazolam is easily administered and accepted by children. But, it's therapeutic drug concentration has not been established. The purpose of this study was to compare sedation effect and physiologic parameter of oral midazolam which palliate demerits of intramuscular administration in sedating young pediatric patients with intramuscular midazolam Twelve negative children, mean age 62.5 months, who needed at least two separate restorative visits, requiring local anesthesia participated in this study. On every visit, one of the following 2 different sedative regimen was given : (1) 0.30mg/kg midazolam by intramuscular administration (2) 0.75mg/kg by oral administration. Physiologic parameter(oxygen saturation, heart rate) was recorded by ten procedure and behavior was videotaped and rated using Ohio State University Behavior Rating Scale and Automated Counting System by one investigator, blind to administration route. The analyzed sedative effect of oral midazolam resulted in good sedative effect, comparing to intramuscular route. And there is no statistically difference between oral and intramuscular administration of midazolam(p>0.05).

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