TY - JOUR
T1 - Tramadol/acetaminophen for the treatment of acute migraine pain
T2 - Findings of a randomized, placebo-controlled trial
AU - Silberstein, Stephen D.
AU - Freitag, Frederick G.
AU - Rozen, Todd D.
AU - Kudrow, David B.
AU - Hewitt, David J.
AU - Jordan, Donna M.
AU - Fisher, Alan C.
AU - Rosenthal, Norman R.
PY - 2005
Y1 - 2005
N2 - 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 ≤ .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 ≤ .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.
AB - 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 ≤ .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 ≤ .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.
KW - Acetaminophen
KW - Headache
KW - Migraine
KW - Pain
KW - Tramadol
UR - http://www.scopus.com/inward/record.url?scp=33645727768&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=33645727768&partnerID=8YFLogxK
U2 - 10.1111/j.1526-4610.2005.00264.x
DO - 10.1111/j.1526-4610.2005.00264.x
M3 - Article
C2 - 16324164
AN - SCOPUS:33645727768
SN - 0017-8748
VL - 45
SP - 1317
EP - 1327
JO - Headache
JF - Headache
IS - 10
ER -