|
HPβCD-diclofenac (n=318) |
Ketorolac (n=142) |
Placebo (n=148) |
p-valuea |
| Mean age, years (SD) |
48.9 (14.1) |
48.0 (14.7) |
48.6 (14.1) |
0.81 |
| Gender |
| Female, n (%) |
233 (73.3) |
107 (75.4) |
107 (72.3) |
0.83 |
| Male, n (%) |
85 (26.7) |
35 (24.6) |
41 (27.7) |
|
| Procedure typeb |
| Abdominal/pelvic, n (%) |
173 (54.4) |
82 (57.7) |
76 (51.4) |
0.55 |
| Orthopedic, n (%) |
145 (45.6) |
60 (42.3) |
72 (48.6) |
|
| Mean procedure duration, h (SD) |
1.17 (0.69)c |
1.13 (0.65)d |
1.19 (0.71) |
0.76 |
| Mean doses received (SD) |
7.3 ( 3.4) |
7.5 ( 3.5) |
6.2 ( 3.7) |
-- |
| 1-6 doses, n (%) |
101 (31.8) |
43 (30.3) |
71 (48.0) |
-- |
| 7-8 doses, n (%) |
150 (47.2) |
67 (47.2) |
53 (35.8) |
-- |
| >8 doses, n (%) |
67 (21.1) |
32 (22.5) |
24 (16.2) |
-- |
| Concomitant anticoagulant |
| No, n (%) |
258 (81.1) |
113 (79.6) |
113 (76.4) |
-- |
| Yes, n (%) |
60 (18.9) |
29 (20.4) |
35 (23.6) |
0.49 |
| Heparin, n (%)e |
53 (16.7) |
25 (17.6) |
33 (22.3) |
0.33 |
| Coumadin, n (%) |
12 (3.8) |
6 (4.2) |
4 (2.7) |
0.77 |
| Warfarin, n (%) |
1 (0.3) |
0 |
0 |
-- |
| Concomitant medication with potential anticoagulant effectsf |
| No, n (%) |
180 (56.6) |
71 (50.0) |
81 (54.7) |
-- |
| Yes, n (%) |
138 (43.4) |
71 (50.0) |
67 (45.3) |
0.42 |
aFrom ANOVA for numerical variables and Cochran–Mantel–Haenszel test for categorical variables;
bMost common procedures (>5% of subjects in all treatment groups): abdominal hysterectomy, abdominal surgery, bunionectomy/foot bone, inguinal hernia repair, knee replacement, vaginal hysterectomy, other;
cn=316;
dn=141;
eIncludes heparin, heparin sodium, enoxaparin, enoxaparin sodium, Lovenox;
fIncludes acetic acid derivatives and related substances, heparin, other antithrombotics, oxicams, platelet aggregation inhibitors, propionic acid derivatives, salicylic acid and derivatives, vitamin K antagonists (Coumadin, warfarin). |
|
