EVALUATION OF 2 OPIOID-ACETAMINOPHEN COMBINATIONS AND PLACEBO IN POSTOPERATIVE ORAL-SURGERY PAIN

Study Objective. To determine the relative analgesic potency and adver se effect liability of hydrocodone bitartrate 7.5 mg with acetaminophe n 500 mg, codeine phosphate 30 mg with acetaminophen 300 mg, and place bo in the treatment of pain following oral surgery. Design. Randomized , double-blind, single-dose, placebo-controlled, parallel-group study with self-ratings at 30 minutes and then at hourly intervals from hour 1 to hour 6. Setting. Private, oral surgery practice sites. Patients. Three hundred twenty-four outpatients with moderate or severe pain af ter the surgical removal of impacted third molars were selected. One w as lost to follow-up and 32 did not need an analgesic; 232 patients ha d valid efficacy data. Interventions. Patients were treated with a sin gle oral dose of hydrocodone bitartrate 7.5 mg with acetaminophen 500 mg, codeine phosphate 30 mg with acetaminophen 300 mg, or placebo when they experienced steady, moderate or severe pain that, in their opini on, required an analgesic. Using a self-rating record, subjects rated their pain and its relief for 6 hours after medicating; estimates of p eak and total analgesia were derived from these subjective reports. Me asurements and Main Results. This study was a valid analgesic assay. B oth active treatments were significantly superior to placebo for all m easures of analgesic efficacy. The hydrocodone-acetaminophen combinati on was significantly superior to the codeine-acetaminophen combination for total pain relief and the number of evaluations with 50% relief. Both active treatments manifested an analgesic effect within 30 minute s; the effect persisted for 5 hours for the codeine combination and 6 hours for the hydrocodone combination. Adverse effects were transient, consistent with the pharmacologic profiles of opioids, and none requi red treatment. Conclusions. A slight advantage in analgesic efficacy w as demonstrated in this single-dose study for the hydrocodone-acetamin ophen combination. Repeat-dose studies, however, should be conducted t o determine the clinical significance of the difference in analgesic e ffect of these opioid combinations.