Table 2 Summary of the study designs and population demographics of selected (S)-(nor)ketamine PK models from literature. CRPS-1 complex regional pain syndrome type 1
| Sigtermans et al. [18] | Dahan et al. [30] | Noppers et al. [31] | Fanta et al. [27] | Jonkman et al. [26] | |
|---|---|---|---|---|---|
| Study design | |||||
| Administered drug | (S)-ketamine | (S)-ketamine | (S)-ketamine | (S)-ketamine | (S)-ketamine |
| Mode of administration | Intravenous infusion (2h) | Intravenous infusion (100h) | Intravenous infusion (2h) | Intravenous bolus or oral dose | Inhalations followed by intravenous infusion (0.33 h) |
| Dose | 0.95 mg/kg | 0.07 mg/kg/h to 0.29 mg/kg/h | 0.57 mg/kg and 1.14 mg/kg |
Bolus: 0.125 mg/kg Oral: 0.25 mg/kg |
Inhalation: 25 - 37.5 - 50.0 mg or 25 - 50 - 100 mg Infusion: 20 mg |
| PK-sampling schedule (h) | 0.25 - 0.5 - 0.75 - 1 - 1.25 - 1.5 - 1.75 - 2 - 2.03 - 2.08 - 2.17 - 2.25 - 2.5 - 2.75 - 3 - 3.25 - 3.5 - 4 - 4.5 - 5 | 4 times a day, at change of infusion or at random |
0 - 0.08 - 0.17 - 0.25 - 0.5 - 0.75 - 1 - 1.25 - 1. 5 - 1.75 - 2 - 2.08 - 2.16 - 2.25 - 2.5 - 3 - 3.5 - 4 - 4.5 - 5 | 0.04 - 0.08 - 0.17 - 0.25 - 0.33 - 0.5 - 0.75 - 1 - 1.5 - 2 - 4 - 6 - 8 - 12 - 23.5 | 0.03 - 0.07 - 0.13 - 0.17 - 0.25 - 0.33 - 0.37 - 0.4 - 0.5 - 0.67 - 1 -1.33 - 2 - 3 |
| Sampling methodology | Arterial | Venous | Arterial | Venous | Arterial |
| Demographics | |||||
| Population | Healthy volunteers | CRPS-1 patients | Healthy volunteers | Healthy volunteers | Healthy volunteers |
| N (male) | 20 (10) | 30 (8) | 20 (20) | 11 (11) | 19 (10) |
| Age (year) | 21.7 ± 0.5 | 46 ± 12 | 22.0 (20-29) | 22.3 ± 2.4 | 24 ± 2 |
| BMI (kg/m2) | 22.1 ± 0.5 | n/a | 22.2 (19-28) | 23.6 ± 1.8 | 22 ± 2 |
| Weight (kg) | 69.4 ± 2.4 | 79 ± 19 | Not reported | 77 ± 7.5 | Not reported |