Comparison of Oral Midazolam and Diazepam for Anxiety Management in Minor Oral Surgical Procedures: A Randomized Controlled Trial
Abstract
Purpose: To compare the anxiolytic efficacy, effects on vital signs, retrograde amnesia, and postoperative pain of oral midazolam (7.5 mg) versus oral diazepam (5 mg) in patients undergoing minor oral surgical procedures.Midazolam’s potential co-analgesic effect has been explored in previous dental sedation literature.
Materials and Methods : This prospective, randomized, parallel-design controlled trial enrolled 128 patients (64 per group) undergoing various minor oral surgeries at the Department of Oral and Maxillofacial Surgery, Sudha Rustagi College of Dental Sciences and Research, Faridabad. Patients received either 5 mg oral diazepam (Group I) or 7.5 mg oral midazolam (Group II) 30 minutes preoperatively Anxiety levels were assessed using the Corah Dental Anxiety Scale (pre-medication) and the Depression, Anxiety, and Stress Scale (DASS) (post-procedure). Vital signs (blood pressure, heart rate, oxygen saturation) were monitored at four distinct time points: before sedation, 30 minutes post-medication, during the surgical procedure (at 30-minute intervals), and 15 minutes post-procedure Retrograde amnesia was evaluated using a 6-image recall test, and postoperative pain was assessed using a Numerical Rating Scale (NRS). Statistical analysis was performed using SPSS version 21, employing independent t-tests, repeated measures ANOVA, Mann Whitney U test, and Wilcoxon test, with significance set at p<0.05. Results: Both midazolam and diazepam significantly reduced anxiety levels from baseline (p<0.001 intragroup for both), with no statistically significant difference between the groups in anxiety reduction (p=0.939 intergroup). Oxygen saturation remained stable and within physiological limits in both groups across all time points (all p>0.05). Significant intergroup differences were observed in heart rate during surgery (p=0.045) and 15 minutes post-surgery (p=0.005), with the diazepam group exhibiting a more sustained reduction. Systolic blood pressure showed a more pronounced initial reduction with midazolam, while the diazepam group experienced a significant rebound above baseline post-surgery (p=0.008). Retrograde amnesia levels were comparable between the two groups (p=0.909). Notably, the midazolam group reported significantly lower mean postoperative pain scores compared to the diazepam group (p=0.001).
Conclusions: Both oral midazolam (7.5 mg) and oral diazepam (5 mg) are equally effective in providing anxiolysis for minor oral surgical procedures. Midazolam demonstrated a distinct advantage in reducing postoperative pain, while both drugs maintained stable oxygenation and comparable levels of retrograde amnesia.
