M. Fishbein et al., EVALUATION OF INTRANASAL MIDAZOLAM IN CHILDREN UNDERGOING ESOPHAGOGASTRODUODENOSCOPY, Journal of pediatric gastroenterology and nutrition, 25(3), 1997, pp. 261-266
Background: Intravenous midazolam and opioids are used to produce cons
cious sedation in children undergoing esophagogastroduodenoscopy (EGD)
. However, children may experience significant fear and anxiety before
receiving these medications, especially during separation from parent
s and during venipuncture. Intranasal administration of midazolam repr
esents a noninvasive method of sedating children before anxiety-produc
ing events. The objective of this study was to determine whether preme
dication with intranasal midazolam reduces stress and anxiety of separ
ation from parents and of undergoing venipuncture, while maintaining a
dequate sedation during EGD. Methods: This was a prospective, randomiz
ed, double-blind study in 40 children, aged 2 to 12 years, who were un
dergoing EGD. Patients in group I were premedicated with intranasal pl
acebo (0.9% NaCl) followed 10 minutes later by intravenous midazolam (
0.05 mg/kg) and intravenous meperidine (1 mg/kg). Patients in group II
were premedicated with intranasal midazolam (0.2 mg/kg) followed by i
ntravenous placebo (0.9% NaCl) and intravenous meperidine (1 mg/kg). A
nxiolysis and sedation were scored by a blinded observer, who identifi
ed minor and major negative behaviors during four observation periods:
intranasal drug administration, separation from parents, venipuncture
, and EGD. Results: Premedication with intranasal midazolam significan
tly reduced negative behaviors during separation from parents (p < 0.0
5); however, no difference between regimens was noted during venipunct
ure or EGD. Negative behaviors appeared to increase during administrat
ion of intranasal midazolam or placebo. Conclusions: Premedication wit
h intranasal midazolam is effective in reducing negative behaviors dur
ing separation from parents, while it maintains sedation during the en
doscopic procedure. The benefits of intranasal administration may be n
egated, however, by irritation, and discomfort caused by intranasal dr
ug delivery. (C) 1997 Lippincott-Raven Publishers.