Our principal objective in this study was to evaluate the potential pain reducing effect of i.v. midazolam in patients undergoing oral surgery. One-hundred-twenty-five patients with impacted mandibular third molars requiring removal under local anesthetic were randomized into 2 groups. The first group (n = 64) was administered i.v. midazolam by titration until a clinical end-point of conscious sedation followed by local anesthetic before surgery; the second group (n = 61) was the control and was administered only local anesthetic before surgery. The surgery was performed in a standardized manner in both groups by the same surgeon. Outcome measures were four primary end-points: pain intensity as assessed by a 100-mm visual analogue scale and a 4-point categorized scale hourly for 8 h, time to first analgesic, total analgesic (ibuprofen) consumption over the first 48 h, and a 5-point categorical patient global assessment scale (0 = poor, 1 = fair, 2 = good, 3 = very good, and 4 = excellent). Throughout the 8-h investigation period, patients in the midazolam group reported significantly lower pain intensity scores than those in the control group (19.0 +/- 13.2 mm versus 28.1 +/- 12.8 mm, P < 0.05). The patients in the midazolam group also reported significantly longer time to first analgesic (165.5 +/- 56.5 min versus 202.2 +/- 79.0 min, P < 0.05), less analgesic consumption (1275 +/- 364 mg versus 1688 +/- 407 mg, P < 0.001) and better patient global assessment (3.34 +/- 0.8 versus 2.4 +/- 0.9, P < 0.001). We conclude that systemically administered midazolam is effective in reducing postoperative pain after third molar surgery.
Implications: In this observer blinded study, we found that i.v. midazolam treatment (0.09 mg/kg) has a pain-reducing effect after third molar surgery, thus improving postoperative pain management.