Comparison of the Effects of Intranasal and Oral Midazolam Premedication on Sedation and Separation From Parents for Pediatric Patients.

Abstract

Aim: The aim of this study is to compare the effect of intranasal and oral midazolam administered for premedication to children of preschool age on hemodynamic parameters, sedation, and separation from parents.

Method: A prospective, randomized, single-blind design was adopted, including 60 children aged 2-6 years scheduled for elective surgery under general anesthesia. Participants were randomly assigned into two equal groups using a sealed-envelope randomization technique (Group O, n = 30, 0.5 mg/kg oral midazolam; Group N, n = 30, 0.25 mg/kg intranasal midazolam). The study drug was administered 20 min prior to induction of anesthesia. Vital signs and sedation score levels were recorded every 5 min. At the end of the 20th minute, the separation from parents score was assessed and recorded. Assessments were completed by an anesthesiologist who did not know the method of administration for premedication.

Results: There were no statistically significant differences between the two groups in terms of mean age, sex, height, and weight. In Group N, 11/30 (36%) of patients had different types of nasal irritation identified. In both groups, sedation score values examined in the 10th minute were significantly high compared to the initial values. No statistical significance was observed for the other values. There was no statistically significant difference observed for the mean separation from parents scores in Group N and Group O examined in the 20th minute (p > 0.05).

Conclusion: In our study, 0.25 mg/kg intranasal midazolam and 0.5 mg/kg oral midazolam, administered to children from 2 to 6 years for premedication, were effective methods, with no significant differences between the two kinds of administration in terms of sedation or separation from parents. Due to the nasal irritation emerging in patients with nasal administration, oral midazolam was evaluated as a more preferable method. Trial Registration: ClinicalTrials.gov: NCT07021755.