title: Tramadol/acetaminophen for the treatment of acute migraine pain: findings of a randomized, placebo-controlled trial.
abstract: OBJECTIVE
  To compare tramadol/acetaminophen (APAP) and placebo for the management of acute migraine pain.
  
  
  BACKGROUND
  Tramadol/APAP tablets reduced moderate-to-moderately severe acute pain in controlled studies of other painful conditions.
  
  
  METHODS
  This randomized, double-blind, placebo-controlled, parallel group study enrolled adults with migraine pain as per International Headache Society criteria. Subjects took tramadol/APAP (total dose, 75 mg/650 mg) or placebo for a typical migraine with moderate-to-severe pain. Severity of pain and migraine-related symptoms were recorded before study medication and at 0.5, 1, 2, 3, 4, 6, and 24 hours after study medication.
  
  
  RESULTS
  Efficacy analyses included 305 subjects (154 tramadol/APAP and 151 placebo). Treatment response was higher for tramadol/APAP than a placebo at 2 hours after dosing (55.8% vs. 33.8%, P < .001) and at every other assessment from 30 minutes (12.3% vs. 6.6%) through 6 hours (64.9% vs. 37.7%) (all P< or = .022). Subjects in the tramadol/APAP group were more likely than those in the placebo group to be pain-free at 2 hours (22.1% vs. 9.3%), 6 hours (42.9% vs. 25.2%), and 24 hours (52.7% vs. 37.9%) (all P< or = .007). Two hours after dosing, moderate-to-severe symptoms that were less common for tramadol/APAP than placebo included photophobia (34.6% vs. 52.2%, P= .003) and phonophobia (34.3% vs. 44.9%, P = .008), but not migraine-related nausea (38.5% vs. 29.4%, P= .681). Treatment-related adverse events included nausea, dizziness, vomiting, and somnolence.
  
  
  CONCLUSIONS
  Tramadol/APAP reduces the severity of pain, photophobia, and phonophobia associated with migraine headache, but does not reduce migraine-associated nausea. Tramadol/APAP might be an appropriate option for the management of moderate-to-severe migraine headache.
authors.affiliation: Jefferson Medical College, Philadelphia, PA, USA.
authors.forename: Stephen D
authors.initials: SD
authors.lastname: Silberstein
authors.forename: Frederick G
authors.initials: FG
authors.lastname: Freitag
authors.forename: Todd D
authors.initials: TD
authors.lastname: Rozen
authors.forename: David B
authors.initials: DB
authors.lastname: Kudrow
authors.forename: David J
authors.initials: DJ
authors.lastname: Hewitt
authors.forename: Donna M
authors.initials: DM
authors.lastname: Jordan
authors.forename: Alan C
authors.initials: AC
authors.lastname: Fisher
authors.forename: Norman R
authors.initials: NR
authors.lastname: Rosenthal
mesh_terms: D000082:Acetaminophen / Q000009:adverse effects / Q000627:therapeutic use*; D000208:Acute Disease; D000328:Adult; D018712:Analgesics, Non-Narcotic / Q000009:adverse effects / Q000627:therapeutic use*; D000701:Analgesics, Opioid / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000188:drug therapy*; D010147:Pain Measurement; D014147:Tramadol / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D018712:Analgesics, Non-Narcotic; D000701:Analgesics, Opioid; D004338:Drug Combinations; D000082:Acetaminophen; D014147:Tramadol