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).
Table 1: Summary of baseline demographics and surgical characteristics. SD=standard deviation