Table 2.
Safety assessments in the three groups.
| Placebo (n = 20) | Ibuprofen 400 mg (n = 17) | Ibuprofen 800 mg (n = 19) | P | |
|---|---|---|---|---|
| General disorders | ||||
| Pyrexia | 18 (90%) | 14 (82%) | 14 (74%) | 0.413 |
| Headache and dizziness | 1 (5%) | 2 (12%) | 1 (5%) | 0.675 |
| Cough | 6 (30%) | 7 (41%) | 10 (53%) | 0.357 |
| Postoperative inflammation | 1 (5%) | 2 (12%) | 1 (5%) | 0.675 |
| Epigastric pain | 1 (5%) | 5 (29%) | 1 (5%) | 0.041* |
| Skin and subcutaneous tissue disorders | ||||
| Pruritus | 3 (15%) | 2 (12%) | 1 (5%) | 0.608 |
| Gastrointestinal disorders | ||||
| Nausea | 7 (35%) | 5 (29%) | 2 (11%) | 0.186 |
| Vomiting | 2 (10%) | 1 (6%) | 0 | 0.38 |
| Exhaust within 48 h | 1 (5%) | 4 (24%) | 1 (5%) | 0.123 |
| Gastrointestinal bleeding | 0 | 0 | 0 | >0.999 |
| Liver disorders | ||||
| Alanine aminotransferase increased | 0 | 0 | 0 | >0.999 |
| Aspartate aminotransferase increased | 0 | 0 | 0 | >0.999 |
| Renal and urinary disorders | ||||
| Urinary tract infection | 7 (35%) | 3 (18%) | 2 (11%) | 0.159 |
| Blood urea nitrogen increased | 0 | 0 | 0 | >0.999 |
| Creatinine increased | 0 | 0 | 0 | >0.999 |
| Clinical laboratory assessments | ||||
| Hemoglobin decreased | 1 (5%) | 1 (6%) | 1 (5%) | 0.993 |
| Prothrombin time extended | 0 | 0 | 0 | >0.999 |
| Activated partial thromboplastin time | 0 | 0 | 1 (5%) | 0.371 |
| extended | 2 (10%) | 2 (12%) | 2 (11%) | 0.985 |
| Plasma fibrinogen increased | 1 (5%) | 0 | 0 | 0.400 |
| Plasma D-dimer increased | ||||
*Recalculated by Fisher’s exact test. P = 0.059, placebo group vs. ibuprofen 400 mg group; P = 0.744, placebo group vs. ibuprofen 800 mg group; P = 0.067, ibuprofen 400 mg group vs. ibuprofen 800 mg group.