title: A double-blind placebo-controlled comparison of tramadol/acetaminophen and tramadol in patients with postoperative dental pain.
abstract: The objective of this study was to compare the analgesic efficacy of tramadol/acetaminophen (APAP) (total dose 75 mg/650 mg) and tramadol (total dose 100 mg) for the control of pain after oral surgery. A total of 456 patients with moderate-to-severe pain within 5 h after extraction of two or more third molars were randomized to receive two identical encapsulated tablets containing tramadol/APAP 37.5 mg/325 mg, tramadol 50 mg, or placebo. Tramadol/APAP was superior to tramadol (P < 0.001) or placebo (P < 0.001) on all efficacy measures: total pain relief (PAR) over 6 h (7.4, 2.5, and 1.5, respectively, on a scale of 0-24); sum of pain intensity differences (PIDs) (3.1, 0.6, and 0.1, respectively, on a scale of -6 to 18); and sum of PAR and PID (10.5, 3.1, and 1.6, respectively, on a scale of -6 to 42). Median times to onset of perceptible and meaningful PAR were 37.6 and 126.5 min, respectively, for the tramadol/APAP group (P < 0.001) for each, compared with tramadol and placebo arms). The most common adverse events with active treatment were nausea, dizziness, and vomiting; these events occurred more frequently in the tramadol group than in the tramadol/APAP group. This study established the superiority of tramadol/APAP 75 mg/650 mg over tramadol 100 mg in the treatment of acute pain following oral surgery.
authors.affiliation: Austin Oral Surgery Associates, 706A Ben White Blvd West, Austin, TX 78704, USA Ortho-McNeil Pharmaceutical, Inc., Raritan, NJ, USA.
authors.forename: James R
authors.initials: JR
authors.lastname: Fricke
authors.forename: David J
authors.initials: DJ
authors.lastname: Hewitt
authors.forename: Donna M
authors.initials: DM
authors.lastname: Jordan
authors.forename: Alan
authors.initials: A
authors.lastname: Fisher
authors.forename: Norman R
authors.initials: NR
authors.lastname: Rosenthal
mesh_terms: D000082:Acetaminophen / Q000008:administration & dosage* / Q000009:adverse effects; D000293:Adolescent; D000328:Adult; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage / Q000009:adverse effects; D000701:Analgesics, Opioid / Q000008:administration & dosage / Q000009:adverse effects; D004244:Dizziness / Q000139:chemically induced; D004311:Double-Blind Method; D004338:Drug Combinations; D004357:Drug Synergism; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D010147:Pain Measurement; D010149:Postoperative Pain / Q000188:drug therapy* / Q000209:etiology / Q000523:psychology; D014098:Toothache / Q000188:drug therapy* / Q000209:etiology / Q000523:psychology; D014147:Tramadol / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D018712:Analgesics, Non-Narcotic; D000701:Analgesics, Opioid; D004338:Drug Combinations; D000082:Acetaminophen; D014147:Tramadol