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: Stephen D Silberstein, Frederick G Freitag, Todd D Rozen, David B Kudrow, David J Hewitt, Donna M Jordan, Alan C Fisher, Norman R Rosenthal, CAPSS-223 Investigators
• Journal: Headache (Headache) 2005 Nov-Dec Vol. 45 Issue 10 Pg. 1317-27 ISSN: 0017-8748 [Print] United States
• PMID: 16324164 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Analgesics, Non-Narcotic
• Analgesics, Opioid
• Drug Combinations
• Acetaminophen
• Tramadol

Topics

• Acetaminophen (adverse effects, therapeutic use)
• Acute Disease
• Adult
• Analgesics, Non-Narcotic (adverse effects, therapeutic use)
• Analgesics, Opioid (adverse effects, therapeutic use)
• Double-Blind Method
• Drug Combinations
• Female
• Humans
• Male
• Middle Aged
• Migraine Disorders (drug therapy)
• Pain Measurement
• Tramadol (adverse effects, therapeutic use)