tapentadol and Toothache

Tapentadol is a novel, centrally acting analgesic with two modes of action, combining mu-opioid agonism and norepinephrine reuptake inhibition in a single molecule. We compared the efficacy and tolerability of tapentadol and a standard dose of morphine with placebo in a model of moderate-to-severe postoperative dental pain.. Patients undergoing mandibular third molar extraction and experiencing moderate-to-severe pain postsurgery were randomized to receive single, oral doses of tapentadol HCl (25, 50, 75, 100, or 200 mg), morphine sulfate (60 mg), ibuprofen (400 mg; used to establish model sensitivity), or placebo. Mean total pain relief over 8 h (TOTPAR-8) was the primary end point. Secondary end points included mean total pain relief over 4 h (TOTPAR-4) and onset of analgesia. Pairwise comparisons of study drug to placebo were assessed using the Fisher least significant difference test. Adverse events were recorded.. Four hundred patients were randomized to treatment and completed the study. Compared with placebo, mean TOTPAR-8 was significantly greater for tapentadol HCl 50 mg (P = 0.041), 75 mg (P = 0.001), 100 mg (P < 0.001), and 200 mg (P < 0.001); morphine sulfate 60 mg (P < 0.001); and ibuprofen 400 mg (P < 0.001) in a nonparametric analysis of the primary end point. The significantly higher TOTPAR-8 score for ibuprofen compared with placebo established the sensitivity of the model. Mean TOTPAR-4 was higher and onset of action appeared more rapid for tapentadol HCl 200 mg than morphine sulfate 60 mg. Pain relief scores with morphine sulfate 60 mg were between those of tapentadol HCl 100 and 200 mg. The incidence of nausea and vomiting appeared to be lower with all doses of tapentadol HCl compared with morphine sulfate 60 mg, but was not statistically significant.. Single oral doses of tapentadol 75 mg or higher effectively reduced moderate-to-severe postoperative dental pain in a dose-related fashion and were well-tolerated relative to morphine. These data suggest that tapentadol is a highly effective, centrally acting analgesic with a favorable side effect profile and rapid onset of action.

Topics: Adult; Analgesics; Double-Blind Method; Female; Humans; Ibuprofen; Male; Morphine; Pain, Postoperative; Phenols; Receptors, Opioid, mu; Tapentadol; Toothache

Tapentadol HCI is an opioid (narcotic) analgesic, which also inhibits norepinephrine reuptake. While it appears to display a somewhat lower incidence of nausea and constipation than oxycodone 10 mg to 15 mg, its analgesic efficacy in acute postsurgical dental pain is inferior to ibuprofen 400 mg. Like other single-entity opioids, tapentadol should not be used as a first-line agent for postsurgical dental pain but can be employed as an add-on drug for breakthrough pain in patients already using a regimen of a non-steroidal anti-inflammatory drug and/or acetaminophen.

Topics: Analgesics, Opioid; Anti-Inflammatory Agents, Non-Steroidal; Drug Interactions; Humans; Neurotransmitter Uptake Inhibitors; Oral Surgical Procedures; Pain, Postoperative; Phenols; Tapentadol; Toothache