comparative study on the efficacy of rectal diazepam and midazolam for reduction of pre-operative anxiety in pediatric patients

ABSTRACT

Children, due to their great parental dependency, are amongst the cases that should receive preoperatively medication to reduce their fear and anxiety. The objective of this study was to compare the efficacy of rectal diazepam and midazolam for this purpose in pediatric patients scheduled for elective surgery. 60 children, aged between 1 and 6 years, scheduled for elective surgery, were included in this double blind, randomized controlled trial. Patients were randomly allocated into three equal groups. Patients in midazolam and diazepam groups received the drugs 0.3 mg/kg and 0.5 mg/kg respectively [in normal saline at a final volume of 2.5 ml] and placebo group received only 2.5 ml of normal saline 20 min before arriving operation room through rectal applicator. Sedation and anxiety scores at the time of separation from their parents before arriving operating room were recorded for all groups. There was a significant reduction in anxiety level in midazolam and diazepam groups as compared to placebo group [P<0.001]. Sedation rate was 65% for midazolam, 60% for diazepam, and 15% for placebo group [P=0.007]. There were no significant changes in hemodynamic parameters in the three study groups. With respect to effective anxiolytic and sedative activity, rectal midazolam [0.3 mg/Kg] and diazepam [0.5 mg/Kg] can be used as an anesthetic premedicant for children at pre-operative period and their use is safe regarding hemodynamic variables and related side-effects