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Randomized control trial of buccal mucosa administration vs intramuscular injection of midazolam on infants and children with congenital heart diseaseundergoing diagnostic procedures.


Ma Rowena C. Sanchez,
Bernadette Azcueta,
Concepcion Uy-Santos

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Publication Information

Publication Type
Publication Sub Type
Journal Article, Original
Philippine Heart Center Journal
Publication Date
January-December 2005


BACKGROUND: Objectives: To compare the effect of buccalmucosa vs Intramuscular administration of Midazalom based on the level of anxiety, sedation, separation, and behavior/induction score; onset of sedation/anxiolysis (time from administration to first change in sedation/anxiolysis), length of effective sedation/anxiolysis and side effects/adverse effect

MATERIALS AND METHODS: Infants and children less than 5 years old, seen at the Philippine Heart Center or congenital heart disease who needs sedation for a diagnostic work-up specifically 2D echo were included in the study. The group was divided into two based on the route of drug administration. Group 1: Midazolam administered via buccal mucosa (Midazolam IV/IM preparation 0.2 mg/kg per dose was administered in between the cheeks and the gums) and Group 2: Midazolam administered via intramuscular injection (Midazolam IV/IM preparation 0.2 mg/kg per dose was administered intramuscularly).
Study Design: Randomized Control Trial Computer generated randomized sampling was employed.

RESULTS: Forty-two patients were included in the study, with age ranging from 14.55 +/- 14.36 mos and 22.95 +/- 15. 73 mos in Group I and II respectively. After administration of Midazolam, there was no significant difference between the two groups with regards to the onset of sedation and length of effective sedation based on the sedation, separation and behavior scoring. However, based on anxiety score, there was a significant difference between the two groups, with group 1 noted to be less anxious and with more prolonged effect. Drowsiness was the only side effect noted on both groups.

CONCLUSION: IM/IV preparation of Midazolam administered via the buccal mucosa could offer a less painful, safe and equally effective alternative route in achieving sedation and anxiolysis in infants and children with congenital heart disease undergoing diagnostic procedures like 2D-echo.

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