Characteristics of sickle-cell disease vaso-occlusive crises (VOCs) at inclusion, therapeutic impact, and adverse events as a function of the treatment-group assignment
| Characteristic . | Placebo group . | Ketoprofen group . |
|---|---|---|
| At inclusion, n | 33 | 33 |
| Age, y | 27 ± 7* | 26 ± 7 |
| Body mass index | 21 ± 3 | 21 ± 2 |
| VOC duration before inclusion, hours | 31 ± 13 | 29 ± 15 |
| Morphine dose before inclusion, mg | 44.2 ± 37 | 43.7 ± 32 |
| VAS score, mm | 71 ± 16 | 73 ± 16 |
| Categorical pain score, points | 5.7 ± 3.6 | 5.6 ± 2.9 |
| Number of pain sites | 2.5 ± 1.5 | 2.5 ± 1.3 |
| Maximal pain score for 1 site | 2.5 ± 0.6 | 2.6 ± 0.5 |
| Leukocyte count, 109/L | 14.4 ± 3.7 | 14.8 ± 4.2 |
| Hemoglobin value, g/dL | 9.2 ± 1.3 | 9.5 ± 1.1 |
| Platelet count, 109/L | 393.7 ± 102 | 373.9 ± 128 |
| Lactate dehydrogenase, IU/L | 357 ± 127 | 413 ± 190 |
| C-reactive protein, g/L | 63 ± 48 | 64 ± 69 |
| Treatment impact, n | 26† | 26† |
| Duration of VOC, median (IQR), h | 50 (36-103) | 51 (35.5-87) |
| Morphine dose, median (IQR), mg | 88 (52.5-262.5) | 110 (46-195) |
| Total CPS, median (IQR)‡ | 0.4 (0.2-0.7) | 0.4 (0.2-0.7) |
| Total VAS score, median (IQR), mm‡ | 9.6 (5.8-33.2) | 12.6 (4.8-23.2) |
| Adverse events, n | 33 | 33 |
| Abdominal pain | 1 | 0 |
| Infection (urinary tract and bronchitis) | 0 | 2 |
| Constipation | 2 | 0 |
| Epigastralgia | 2 | 1 |
| Facial edema | 1 | 0 |
| Fever | 5 | 5 |
| Hepatic cytolysis | 1 | 0 |
| Myocardial repolarization abnormality | 0 | 1 |
| Nausea/vomiting | 3 | 4 |
| Pruritus | 2 | 2 |
| Somnolence | 1 | 0 |
| Tachycardia | 1 | 0 |
| Urinary retention | 0 | 1 |
| Total of adverse events | 19 | 16 |
| Characteristic . | Placebo group . | Ketoprofen group . |
|---|---|---|
| At inclusion, n | 33 | 33 |
| Age, y | 27 ± 7* | 26 ± 7 |
| Body mass index | 21 ± 3 | 21 ± 2 |
| VOC duration before inclusion, hours | 31 ± 13 | 29 ± 15 |
| Morphine dose before inclusion, mg | 44.2 ± 37 | 43.7 ± 32 |
| VAS score, mm | 71 ± 16 | 73 ± 16 |
| Categorical pain score, points | 5.7 ± 3.6 | 5.6 ± 2.9 |
| Number of pain sites | 2.5 ± 1.5 | 2.5 ± 1.3 |
| Maximal pain score for 1 site | 2.5 ± 0.6 | 2.6 ± 0.5 |
| Leukocyte count, 109/L | 14.4 ± 3.7 | 14.8 ± 4.2 |
| Hemoglobin value, g/dL | 9.2 ± 1.3 | 9.5 ± 1.1 |
| Platelet count, 109/L | 393.7 ± 102 | 373.9 ± 128 |
| Lactate dehydrogenase, IU/L | 357 ± 127 | 413 ± 190 |
| C-reactive protein, g/L | 63 ± 48 | 64 ± 69 |
| Treatment impact, n | 26† | 26† |
| Duration of VOC, median (IQR), h | 50 (36-103) | 51 (35.5-87) |
| Morphine dose, median (IQR), mg | 88 (52.5-262.5) | 110 (46-195) |
| Total CPS, median (IQR)‡ | 0.4 (0.2-0.7) | 0.4 (0.2-0.7) |
| Total VAS score, median (IQR), mm‡ | 9.6 (5.8-33.2) | 12.6 (4.8-23.2) |
| Adverse events, n | 33 | 33 |
| Abdominal pain | 1 | 0 |
| Infection (urinary tract and bronchitis) | 0 | 2 |
| Constipation | 2 | 0 |
| Epigastralgia | 2 | 1 |
| Facial edema | 1 | 0 |
| Fever | 5 | 5 |
| Hepatic cytolysis | 1 | 0 |
| Myocardial repolarization abnormality | 0 | 1 |
| Nausea/vomiting | 3 | 4 |
| Pruritus | 2 | 2 |
| Somnolence | 1 | 0 |
| Tachycardia | 1 | 0 |
| Urinary retention | 0 | 1 |
| Total of adverse events | 19 | 16 |
VAS indicates visual analog scale; CPS, categorical pain score; and IQR, interquartile range.
No significant differences between treatment groups and no trends toward significance were found.
Values are means ± standard deviation.
Treatment failures (8 blood transfusions, 5 acute chest syndromes, and 1 sepsis) led to the exclusion of 7 patients in each group from the analysis.
Total VAS and total CPS are the averages of the patients' daily mean values for the 2 scores.