Table 1.
The primary outcome sum pain intensity over 6 h (SPI), SPI for each sex, baseline pain at drug intake, number needed to treat (NNT), number needed to prevent rescue drug intake (NNTp), and rescue drug details for each trial group are shown. Present pain was scored on numerical rating scales (0–10 NRS) ranging from
| Paracetamol 1000 mg Ibuprofen 400 mg |
Paracetamol 1000 mg Codeine 60 mg |
Paracetamol 1000 mg Ibuprofen 400 mg Codeine 60 mg |
Placebo | |
|---|---|---|---|---|
| n = 50 | n = 50 | n = 50 | n = 50 | |
| F/M = 25/25 | F/M = 28/22 | F/M = 29/21 | F/M = 26/24 | |
| Pain at drug intake (NRS) | ||||
| Median | 6.0 | 5.0 | 5.5 | 5.0 |
| (Q1, Q3) | (4.8, 7.0) | (4.0, 6.0) | (4.0, 6.3) | (4.0, 6.3) |
| Median (females) | 6.0 | 5.5 | 6.0 | 6.0 |
| (Q1, Q3) | (5.0, 7.0) | (4.3, 7.0) | (5.0, 7.0) | (4.8, 7.0) |
| Median (males) | 6.0 | 5.0 | 5.0 | 5.0 |
| (Q1, Q3) | (4.0, 7.0) | (4.0, 6.0) | (4.0, 6.0) | (4.0, 6.0) |
| Mean | 6.0 | 5.5 | 5.5 | 5.5 |
| (95% CI) | (5.6, 6.4) | (5.1, 5.9) | (5.1, 5.9) | (5.1, 5.9) |
| Mean (females) | 6.2 | 5.8 | 5.8 | 5.7 |
| (95% CI) | (5.6, 6.8) | (5.2, 6.4) | (5.3, 6.3) | (5.2, 6.3) |
| Mean (males) | 5.7 | 5.2 | 5.2 | 5.3 |
| (95% CI) | (5.2, 6.3) | (4.7, 5.7) | (4.6, 5.8) | (4.8, 5.7) |
| Primary variable | ||||
| Sum pain intensity (SPI) | ||||
| Median | 44.5 | 62.5 | 39.5 | 89.0 |
| (Q1, Q3) | (30.8, 56.5) | (40.0, 84.3) | (26.8, 56.3) | (75.0, 116.3) |
| Mean | 47.6 | 65.2 | 43.5 | 94.3 |
| (95% CI) | (42.2, 53.0) | (56.0, 74.4) | (37.7, 49.3) | (87.7, 100.9) |
| Median (females) | 44.0 | 71.5 | 49.0 | 90.0 |
| (Q1, Q3) | (33.5, 55.0) | (53.5, 92.5) | (33.0, 66.0) | (80.3, 119.3) |
| Mean (females) | 46.2 | 73.3 | 50.7 | 95.7 |
| (95% CI) | (39.5, 53.0) | (61.1, 85.5) | (42.7, 58.7) | (86.0, 105.4) |
| Median (males) | 47.0 | 43.0 | 29.0 | 89.0 |
| (Q1, Q3) | (28.0, 60.5) | (33.8, 69.3) | (26.0, 39.5) | (74.3, 115.8) |
| Mean (males) | 48.9 | 54.8 | 33.6 | 92.8 |
| (95% CI) | (40.1, 57.8) | (41.0, 68.6) | (26.6, 40.6) | (83.2, 102.3) |
| Secondary variables | ||||
| NNT | 1.8 | 2.6 | 1.7 | n/a |
| NNTp | 1.5 | 5.0 | 1.7 | n/a |
| Rescue drug intake | ||||
| Patients/no tablets | 4/6 | 28/51 | 8/12 | 38/85 |