Objectives: To compare the efficacy and safety of tramadol/acetaminophen 37.5/325 mg tablets (TRAM/APAP) and hydrocodone bitartrate/acetaminophen 10/650 mg tablets (HC/APAP) for dental pain.

Methods: Randomized, doubled-blind, placebo- and active-controlled, single-dose, parallel study in 200 adults experiencing at least moderate pain (Pain Visual Analog Score >50/100 mm) following extraction of >2 impacted third molars. Subjects received 1 or 2 TRAM/APAP tablets, 1 HC/APAP tablet, or placebo. Pain intensity and relief were reported 30 minutes and then hourly for 8 hours, and time to onset of perceptible pain relief was recorded. Summary scores of pain relief and intensity over 4 hours and 8 hours were primary outcomes.

Results: Baseline characteristics were similar among groups. One TRAM/APAP tablet was more effective than placebo for select outcomes over 4 hours; 2 TRAM/APAP tablets and 1 HC/APAP tablet were more effective than placebo for up to 8 hours. Among treatment groups, 2 TRAM/APAP tablets were more effective than 1 TRAM/APAP tablet over 4 hours for total pain relief (TOTPAR, P=.031), sum of pain intensity differences (SPID, P=.017), and sum of pain relief and intensity differences (SPRID, P=.023). Two TRAM/APAP tablets were comparable to HC/APAP throughout for TOTPAR (P ³ .082), SPID (P ³ .144), and SPRID (P ³ .095). All treatments had faster onset than placebo; median onset of perceptible pain relief for two TRAM/APAP tablets was 33.3 minutes. The overall incidence of adverse events was lower for TRAM/APAP tablets than for HC/APAP or placebo, and the incidence of nausea and vomiting with two TRAM/APAP tablets was approximately 50% less than in the HC/APAP group.

Conclusion: TRAM/APAP tablets provide rapid, dose-dependent pain relief. The use of two TRAM/APAP tablets is an effective and safe alternative to HC/APAP for dental pain.

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