Two randomized, double-blind, parallel-group single-dose 2 x 2 factorial an
algesic studies compared a single-dose or a 2-tablet dose of a combination
of 7.5 mg hydrocodone bitartrate with 200 mg ibuprofen with each constituen
t alone and with a placebo in women with moderate or severe postoperative p
ain from abdominal or gynecologic surgery. A nurse-observer recorded patien
t reports of pain intensity and pain relief periodically for 8 hours. In bo
th studies, the combination was significantly superior to placebo for sum o
f the pain intensity differences (SPID), total pain relief (TOTPAR), peak p
ain intensity difference (PID) and pain relief, global evaluation, and time
to remedication, The combination was likewise significantly superior to bo
th hydrocodone and ibuprofen for most of these summary measures of analgesi
a. In a factorial analysis, both the hydrocodone and ibuprofen effects were
significant for most summary measures of analgesia, whereas results of the
interaction contrast were consistent with the concept that the analgesic e
ffect of the combination represents the additive analgesia of its 2 constit
uents.