Efficacy and safety of naproxen sodium and ibuprofen for pain relief after oral surgery

Abstract

The efficacy and safety of single doses of naproxen sodium 440 mg and ibuprofen 400 mg (Advil® caplets) were evaluated in a randomized, parallel, double-blind, placebo-controlled study conducted at a single site. Of the 207 patients enrolled in the study, 202 patients with postoperative pain after surgical extraction of three or four impacted third molars were treated with study drug and were included in the safety analysis. Two hundred one patients were valid for efficacy analysis. Efficacy was evaluated using categorical scales of pain intensity and pain relief. Pain intensity also was evaluated on a visual analog scale. The time to pain relief and the time to remedication were significantly better ( P < 0.001) with naproxen sodium and ibuprofen than with placebo. The median time to ingestion of back-up medication was 1.1 hours for placebo, 6 hours for ibuprofen, and 7 hours for naproxen sodium. Pain relief was significantly better ( P ⩽ 0.023) with naproxen sodium and ibuprofen than with placebo at all time points beginning at 30 minutes. Naproxen sodium was significantly better ( P ⩽ 0.026) than ibuprofen at hours 8 through 12 for pain relief and categorical pain intensity scores. There were no serious adverse events or deaths. Both naproxen sodium and ibuprofen were well tolerated and provided pain relief superior to that of placebo. The duration of pain relief was longer with naproxen sodium than with ibuprofen.