Premedication with orally administered midazolam in adults undergoing diagnostic upper endoscopy: a double-blind placebo-controlled randomized trial.
BACKGROUND
A double-blind placebo-controlled randomized trial was conducted to investigate the safety and the efficacy of orally administered midazolam as premedication for patients undergoing elective EGD.


METHODS
A total of 130 patients were randomized to receive either 7.5 mg of midazolam orally (n = 65) or a placebo (n = 65) as premedication. Outcomes measures included the anxiety score (visual analog scale) during EGD, overall tolerance, extent of amnesia, overall satisfaction, patient willingness to repeat the procedure, recovery time, and hemodynamic changes after medication.


RESULTS
The median (interquartile range) anxiety score during the procedure in the midazolam group was significantly lower than that in the control group (2.0 [0-4.9] vs. 3.8 [2.1-7.95], p < 0.001). A significantly greater number of patients in the midazolam group graded overall tolerance as "excellent or good" (70.8% vs. 49.2%, p = 0.012) and reported a partial to complete amnesia response (52.3% vs. 32.3%, p = 0.02) when compared with the control group. Patients in the midazolam group were more willing to repeat the procedure if necessary (89.2% vs. 69.2%, p = 0.005). The median (interquartile range) recovery time was significantly longer in the midazolam group than in the control group (5 [5-15] minutes vs. 5 [5-10] minutes, p = 0.014). There were no statistically significant differences in satisfaction score and hemodynamic changes between groups.


CONCLUSIONS
Premedication by oral administration of midazolam is a safe and an effective method of sedation that significantly reduces anxiety and improves overall tolerance for patients undergoing EGD.
Mui
Lik-man
LM
Teoh
Anthony Y B
AY
Ng
Enders K W
EK
Lee
Yuk-tong
YT
Au Yeung
Alex C M
AC
Chan
Yuk-ling
YL
Lau
James Y W
JY
Chung
S C Sydney
SC
D000284:Administration, Oral; D000328:Adult; D014151:Anti-Anxiety Agents / Q000008:administration & dosage*; D001007:Anxiety / Q000209:etiology / Q000517:prevention & control*; D016292:Procedural Sedation; D004311:Double-Blind Method; D016099:Endoscopy, Gastrointestinal / Q000009:adverse effects / Q000379:methods; D005260:Female; D006801:Humans; D008297:Male; D008874:Midazolam / Q000008:administration & dosage*; D011292:Premedication; D011446:Prospective Studies
D014151:Anti-Anxiety Agents; D008874:Midazolam