Table 1.
Characteristics of STOP Pain patients and efficacy and safety parameters overall and for subjects with missing genetic data.
| Overall | Missing | ||
|---|---|---|---|
| n (%) | n (%) | p-Value | |
| 74 | 13 | ||
| Gender | |||
| Male | 40 (54.05) | 9 (69.23) | 0.375 * |
| Female | 34 (45.95) | 4 (30.77) | |
| Age (months) | |||
| 0–36 | 21 (28.38) | 2 (15.38) | |
| >36–144 | 29 (39.19) | 6 (46.15) | 0.695 * |
| >144 | 24 (32.43) | 5 (38.46) | |
| BMI (percentile) | |||
| <25th | 24 (32.43) | 5 (38.46) | |
| 25th–75th | 14 (18.92) | 5 (38.46) | 0.048 * |
| ≥75th | 23 (31.08) | - | |
| Missing | 13 (17.57) | 3 (23.08) | |
| Diagnosis | |||
| Brain Tumor | 4 (5.41) | 2 (15.38) | |
| Histiocytosis | 4 (5.41) | - | |
| Leukemia and Lymphoma | 31 (41.89) | 3 (23.08) | |
| Neuroblastoma | 6 (8.11) | - | 0.387 * |
| Osteosarcoma | 13 (17.57) | 4 (30.77) | |
| Sarcoma | 14 (18.92) | 4 (30.77) | |
| Other | 2 (2.70) | - | |
| Metastasis | |||
| No | 53 (71.26) | 11 (84.62) | 0.500 * |
| Yes | 21 (28.38) | 2 (15.38) | |
| Pain location | |||
| Abdominal | 11 (14.86) | 1 (7.69) | |
| Oral cavity | 37 (50.00) | 6 (46.15) | 0.521 * |
| Skeletal–Muscle | 10 (13.51) | 4 (30.77) | |
| Other | 16 (21.62) | 2 (15.38) | |
| Pain Intensity | |||
| PIto | |||
| Mean ± SD | 4.32 ± 2.146 | 4.46 ± 2.436 | 0.835 § |
| Median (IQ Range) | 4 (3–6) | 4 (4–6) | 0.696 # |
| ∆VAS | |||
| Mean ± SD | −2.36 ± 2.303 | −1.69 ± 3.881 | 0.389 § |
| Median (IQ Range) | −2 (−4–−1) | −1 (−4–0) | 0.525 # |
| Time tot (hours) | |||
| Mean ± SD | 139.59 ± 65.539 | 145.19 ± 55.632 | 0.773 § |
| Median (IQ Range) | 133.75 (100–192) | 128.00 (96–195) | 0.766 # |
| Pain Intensity PIto grouped | |||
| ≤4 | 40 (54.05) | 7 (53.85) | 1.000 * |
| >4 | 34 (45.95) | 6 (46.15) | |
| Drug | |||
| Morphine | 51 (68.92) | 9 (69.23) | |
| Tramadol | 17 (22.97) | 2 (15.38) | |
| Oxycodone | 1 (1.35) | 1 (7.69) | 0.483 * |
| Codeine | 2 (2.70) | - | |
| more than one | 3 (4.05) | 1 (7.69) | |
| Dose (mg/kg) | |||
| Dose24h a | |||
| Mean ± SD | 0.38 ± 0.209 | 0.39 ± 0.266 | 0.875 § |
| Median (IQ Range) | 0.41 (0.193–0.492) | 0.44 (0.167–0.498) | 0.966 # |
| Dosetot | |||
| Mean ± SD | 2.50 ± 1.823 | 2.96 ± 2.052 | 0.401 § |
| Median (IQ Range) | 2.17 (1.200–3.309) | 2.83 (1.330–3.933) | 0.439 # |
| DoseVAS=0 b | |||
| Mean ± SD | 0.73 ± 1.029 | 0.89 ± 1.121 | 0.639 § |
| Median (IQ Range) | 0.32 (0.095–0.906) | 0.45 (0.132–1.048) | 0.438 # |
| Side effects | |||
| Gastrointestinal | 0.738 * | ||
| Yes | 19 (25.68) | 4 (30.77) | |
| No | 55 (74.32) | 9 (69.23) | |
| CNS | 0.641 * | ||
| Yes | 8 (10.81) | 2 (15.38) | |
| No | 66 (89.19) | 11 (84.62) | |
| Total | 0.753 * | ||
| Yes | 24 (32.43) | 5 (38.46) | |
| No | 50 (67.57) | 8 (66.67) |
a Dose24h was available for 72 patients. b DoseVAS=0 was available for 69 patients with genetic analysis and 11 patients with missing genetic data. * Fisher’s exact test. § Student’s t-test. # Mann–Whitney test.