A Randomized, Prospective, Double-Blind Clinical Trial on the Optimal Dose of Oral Midazolam Premedication in Pediatric Day Case Surgery

Abstract

Objectives: Anxiolysis and sedation with oral midazolam are common practice in pediatric anesthesia. The aim of the present study was to evaluate the efficacy and safety of 3 different doses of midazolam as a premedication agent in day case pediatric surgery patients. Methods: This prospective, randomized, double-blind clinical investigation was designed at Medeniyet University Gortepe Education and Training Hospital Department of Anesthesiology and Reanimation. In all, 90 children aged 6 months to 6 years with American Society of Anesthesiologists physical status of class I or II, who were scheduled for inguinal hernia repair or hydrocele operation were included in the study. Patients were randomly allocated into 3 groups to receive midazolam premedication 0.3 mg kg-1 (Group I), 0.5 mg kg-1 (Group II), or 0.75 mg kg-1 (Group III). Psychological, behavioral, and physiological parameters (heart rate, mean arterial pressure, arterial oxygen saturation, respiratory rate, sedation, anxiolysis score and mask toleration score) were recorded at particular time intervals and special stressful events (separation from parents, induction of anesthesia). Adverse events were also noted. Results: Satisfactory sedation was achieved in all groups. At the end of the operation, the sedation score was higher in Group III. The anxiety rating of face mask application was satisfactory in Group II. There were significant differences between groups in hemodynamic variables, oxygen saturation, and respiratory rate. However, they were accepted as clinically insignificant. There was no significant difference in separation scores between the 3 groups. Postoperative vomiting occurred in 3 patients in Group II and in 2 patients in Group III. Also in Group III, recovery was late in 2 patients and agitation was seen in 2 patients. Conclusion: A dose of 0.3-0.75 mg kg-1 oral midazolam can be used safely for the premedication of pediatric patients to provide sufficient sedation, a pleasant separation from the parents, and fair tolerance of face mask application.