One way to ensure adequate sensitivity for analgesic trials is to test
the intervention on patients who have established pain of moderate to
severe intensity. The usual criterion is at least moderate pain on a
categorical pain intensity scale. When visual analogue scales (VAS) ar
e the only pain measure in trials we need to know what point on a VAS
represents moderate pain, so that these trials can be included in meta
analysis when baseline pain of at least moderate intensity is an inclu
sion criterion. To investigate this we used individual patient data fr
om 1080 patients from randomised controlled trials of various analgesi
cs. Baseline pain was measured using a 4-point categorical pain intens
ity scale and a pain intensity VAS under identical conditions. The dis
tribution of the VAS scores was examined for 736 patients reporting mo
derate pain and for 344 reporting severe pain. The VAS scores correspo
nding to moderate or severe pain were also examined by gender. Baselin
e VAS scores recorded by patients reporting moderate pain were signifi
cantly different from those of patients reporting severe pain. Of the
patients reporting moderate pain 85% scored over 30 mm on the correspo
nding VAS, with a mean score of 49 mm. For those reporting severe pain
85% scored over 54 mm with a mean score of 75 mm. There was no differ
ence between the corresponding VAS scores of men and women. Our result
s indicate that if a patient records a baseline VAS score in excess of
30 mm they would probably have recorded at least moderate pain on a 4
-point categorical scale. (C) 1997 International Association for the S
tudy of Pain. Published by Elsevier Science B.V.