M. Palangio et al., Combination hydrocodone and ibuprofen versus combination oxycodone and acetaminophen in the treatment of postoperative obstetric or gynecologic pain, CLIN THER, 22(5), 2000, pp. 600-612
Objective: The objective of this study was to compare the effectiveness of
combination hydrocodone and ibuprofen with that of combination oxycodone an
d acetaminophen in the treatment of moderate to severe postoperative obstet
ric or gynecologic pain.
Background: Hydrocodone 7.5 mg with ibuprofen 200 mg is the only approved f
ixed-dose combination analgesic containing an opioid and ibuprofen.
Methods: This randomized, double-blind, parallel-group, single-dose, active
-comparator, placebo-controlled study compared the effects of a 2-tablet do
se of hydrocodone 7.5 mg and ibuprofen 200 mg with those of a 2-tablet dose
of oxycodone 5 mg and acetaminophen 325 mg and placebo. Analgesia was asse
ssed over 8 hours.
Results: Mean pain relief (PR) scores were similar for the hydrocodone with
ibuprofen and oxycodone with acetaminophen groups (n = 61 and 59, respecti
vely) at 0.5, 1, 1.5, 2, 2.5, 3, 4, and 7 hours and significantly greater f
or the hydrocodone with ibuprofen group at 5, 6, and 8 hours (P less than o
r equal to 0.05). Mean pain intensity difference (PID) scores were similar
for hydrocodone with ibuprofen and oxycodone with acetaminophen at 0.5, 1,
1.5, 2, 2.5, 3, and 4 hours and significantly greater for hydrocodone with
ibuprofen at 5, 6, 7, and 8 hours (P less than or equal to 0.05). Total PR
scores were similar for hydrocodone with ibuprofen and oxycodone with aceta
minophen for the 0- to 3- and 0- to 4-hour intervals and significantly grea
ter for hydrocodone with ibuprofen for the 0- to 6- and 0- to 8-hour interv
als (P < 0.05). The sum of the PID scores was similar for hydrocodone with
ibuprofen and oxycodone with acetaminophen for the 0- to 3-, 0- to 3-, 0- t
o 6-, and 0- to 8-hour intervals. The median estimated time to onset of ana
lgesia, mean peak PR score, median time to remedication, and mean global as
sessment score were similar for hydrocodone with ibuprofen and oxycodone wi
th acetaminophen. Assay sensitivity was demonstrated by the presence of sta
tistically significant differences between both active treatments and place
bo (n = 60). The number of patients experiencing adverse events was similar
for each of the 3 groups (11 [18.0%], hydrocodone with ibuprofen; 7 [11.9%
], oxycodone with acetaminophen; and 6 [10.0%], placebo).
Conclusions: In this study, a 2-tablet dose of combination hydrocodone 7.5
mg and ibuprofen 200 mg was as effective as a 2-tablet dose of combination
oxycodone 5 mg and acetaminophen 325 mg in the treatment of moderate to sev
ere postoperative obstetric or gynecologic pain. Both treatments were super
ior to placebo. The results of this study suggest that the combination of h
ydrocodone 7.5 mg and ibuprofen 200 mg may offer prescribers an additional
option in combination pain therapy.