Double‐Blind Parallel Comparison of Ketoprofen (Orudis®), Acetaminophen Plus Codeine, and Placebo in Postoperative Pain

Abstract

One hundred sixty‐one patients with postoperative pain were treated at a single center in a double‐blind, randomized, parallei study designed to compare the efficacy and safety of single oral doses of ketoprofen (50 and 150 mg), an acetaminophen (650 mg) plus codeine (60 mg) combination, and placebo. From 1 through 4 hours after administration of the study drugs, the mean summed pain intensity difference (SPID) and time‐weighted total pain relief (TOPAR) scores for the three active treatments generally were significantly (P < 0.05) higher than those for placebo but not significantly different from each other. At the 6‐hour evaluation, the ketoprofen groups, but not the acetaminophen‐codeine group, had higher (P < 0.05) mean SPID and TOPAR scores than the placebo group, as a result of a shorter duration of pain relief in the acetaminophen‐codeine group. The 6‐hour TOPAR scores were significantly (P < 0.05) higher for both ketoprofen groups than for the acetaminophen‐codeine group; the ketoprofen 150 mg group also had significantly (P < 0.05) higher mean 6‐hour SPID and global subjective assessment scores. As a result of a higher frequency of somnolence, there was a significantly (P < 0.05) greater incidence of central nervous system adverse drug reactions among patients treated with acetaminophen pius codeine than among those treated with 150 mg of ketoprofen. These results indicate that the analgesic efficacy of both 50 and 150 mg doses of ketoprofen equals that of acetaminophen 650 mg plus codeine 60 mg and the duration of the analgesic effect of ketoprofen is significantly longer.

Using evidence from different sources: an example using paracetamol 1000 mg plus codeine 60 mg

“…Information was available on 17 comparable studies [30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46] in which different dose combinations of paracetamol and codeine were available for at least two trials (Additional material: Table 4). Quality scores were 3 or better for all.…”

Single dose oral ketoprofen and dexketoprofen for acute postoperative pain in adults

“…Dose: Ketoprofen 6.25 mg was given to 35 participants in one treatment arm (Sunshine 1998), 12.5 mg to 138 participants in three treatment arms (Seymour 1996;Seymour 2000;Sunshine 1998), 25 mg to 281 participants in eight treatment arms (Arnold 1990;Cooper 1984;Cooper 1988;Mehlisch 1984;Olson 1999;Olson 2001;Seymour 1996;Sunshine 1998), 50 mg to 314 participants in eight treatment arms (Cooper 1984;McGurk 1998;Mehlisch 1984;Olson 1999;Schreiber 1996;Sunshine 1993;Turek 1988;Vidal 1999), 100 mg to 161 participants in five treatment arms (Arnold 1990;Cooper 1984;Cooper 1988;Mehlisch 1984;Sunshine 1993) and 150 mg to 39 participants in one treatment arm (Turek 1988).…”

“…Eight studies (Cooper 1984;Cooper 1988;McGurk 1998;Mehlisch 1984;Olson 2001;Seymour 1996;Seymour 2000;Sunshine 1998) enrolled participants with dental pain following extraction of at least one impacted third molar, and six studies enrolled participants with pain following other types of surgery (general surgery Arnold 1990; postepisiotomy pain Olson 1999; knee/ankle surgery Schreiber 1996; Caesarean section Sunshine 1993; elective surgery Turek 1988; hallux valgus surgery (bunionectomy)Vidal 1999).…”

“…Study duration: Study duration was 6 hours in eleven studies (Arnold 1990;Cooper 1984;Cooper 1988;McGurk 1998;Mehlisch 1984;Olson 1999;Olson 2001;Seymour 1996;Seymour 2000;Sunshine 1998;Turek 1988), 24 hours in one (Vidal 1999), three days in one Schreiber 1996), and up to seven days in one (Sunshine 1993). These latter three studies included multiple dose phases, but reported results for the first dose separately for at least some relevant outcomes (Schreiber 1996;Sunshine 1993;Vidal 1999).…”

Analgesic Efficacy of Ketoprofen in Postpartum, General Surgery, and Chronic Cancer Pain

“…A total of 37 (23%) patients reported side effects in Study 4; eight patients in the ketoprofen 150 mg group, 14 in the ketoprofen 50 mg group, 11 in the acetaminophen plus codeine group, and 4 patients in the placebo group. Significantly (P < 0.05) more patients in the acetaminophen plus codeine group and the ketoprofen 50 mg group had adverse effects as compared to the placebo group.…”