The aim of this prospective,
randomised, double–blind study
was to evaluate the efficacy of intramuscular
(IM) tramadol 100 mg in
emergency department treatment of
acute migraine attack and to compare
it with that of IM diclofenac
sodium 75 mg. Forty patients who
were admitted to our emergency
department with acute migraine
attack according to the International
Headache Society criteria were
included in the study. Patients were
randomised to receive either tramadol
100 mg (
n=20) or diclofenac
sodium 75 mg (
n=20) intramuscularly.
Patients rated their pain on a
four–point verbal scale (0=none,
1=mild, 2=moderate, 3=severe) at
the beginning of the trial and at 30,
60, 90 and 120 min. At each time
interval, severity of associated
symptoms were also questioned and
recorded. Global evaluation of the
drugs by patients and doctors were
also recorded. Patients were also
asked if they would prefer the same
injection in future visits. Any
adverse events, whether related to
the drug or not, were also recorded.
Patients were followed up by telephone
48 h later to check for any
headache recurrence. Two–hour pain
response rate, which was the primary
endpoint, was 80% for both tramadol
and diclofenac groups. There
were no statistically significant differences
among groups in terms of
48–h pain response, rescue treatment,
associated symptoms’
response, headache recurrence and
adverse event rates. Fifteen (75%)
patients in the tramadol group and
16 (80%) patients in the diclofenac
group stated that they may prefer the
same agent for future admissions. In
selected patients, tramadol 100 mg
IM may be an effective and reliable
alternative treatment choice in acute
migraine attacks.
Key words Migraine treatment - Tramadol - Diclofenac - Randomised controlled trial