Table 2

Patient demographic and baseline characteristics by treatment group (ITT population)

Demographic and baseline characteristicsTRAM/
DKP,
n=260
TRAM/
paracetamol,
n=262
Placebo, n=131
Race (n, %)
 Asian14 (5.4)21 (8.0)6 (4.6)
 Black or African American7 (2.7)3 (1.1)6 (4.6)
 White235 (90.4)233 (88.9)118 (90.1)
 Other4 (1.5)5 (1.9)1 (0.8)
Gender (n, %)
 Female152 (58.5)158 (60.3)78 (59.5)
 Male108 (41.5)104 (39.7)53 (40.5)
Age (years)
 Mean (SD)26.8 (7.48)27.1 (8.13)26.5 (7.67)
 Range18–5218–6318–59
Body mass index
 Mean (SD)23.5 (4.48)23.4 (4.36)23.7 (4.21)
 Range16–4415–4416–40
Pain intensity (NRS-PI)
 Mean (SD)5.7 (1.4)5.5 (1.3)5.6 (1.3)
 4≤ NRS-PI ≤6 (n, %)196 (75.4)210 (80.2)102 (77.9)
 NRS-PI >6 (n, %)63 (24.2)52 (19.8)29 (22.1)
  • 4≤ NRS-PI ≤6 corresponding to moderate pain intensity; NRS-PI >6 corresponding to severe pain intensity.

  • ITT, intention to treat; NRS, Numerical Rating Scale; TRAM/DKP, tramadol/dexketoprofen.