Table 2.
Adverse effects
| SC group (n = 8) | IV Group (n = 8) | Placebo (n = 7) | P-value* | |
|---|---|---|---|---|
| Self-reported AE incidence | ||||
| 6 (75.0) | 6 (75.0) | 7 (100) | 0.78 | |
| Nausea | ||||
| Mild | 2 (25.0) | 1 (12.5) | 0 (0) | |
| Moderate | 0 (0) | 3 (37.5) | 2 (28.6) | 0.53 |
| Severe | 0 (0) | 0 (0) | 0 (0) | |
| Vomiting | ||||
| Mild | 2 (25.0) | 0 (0) | 0 (0) | |
| Moderate | 1 (12.5) | 1 (12.5) | 1 (14.3) | 0.41 |
| Severe | 0 (0) | 0 (0) | 0 (0) | |
| Shivering | ||||
| Mild | 1 (12.5) | 0 (0) | 6 (85.7) | |
| Moderate | 1 (12.5) | 0 (0) | 0 (0) | 0.01** |
| Severe | 0 (0) | 0 (0) | 0 (0) | |
| Sedation | ||||
| Mild | 1 (12.5) | 2 (25.0) | 1 (14.3) | |
| Moderate | 0 (0) | 1 (12.5) | 2 (28.6) | 0.38 |
| Severe | 0 (0) | 0 (0) | 0 (0) | |
| Blurred vision | ||||
| Mild | 1 (12.5) | 3 (37.5) | 1 (14.3) | |
| Moderate | 0 (0) | 0 (0) | 0 (0) | 0.41 |
| Severe | 0 (0) | 0 (0) | 0 (0) | |
| Diplopia | ||||
| Mild | 0 (0) | 1 (12.5) | 1 (14.3) | |
| Moderate | 0 (0) | 0 (0) | 0 (0) | 0.99** |
| Severe | 0 (0) | 0 (0) | 0 (0) | |
| Dizziness | ||||
| Mild | 1 (12.5) | 3 (37.5) | 1 (14.3) | |
| Moderate | 0 (0) | 0 (0) | 0 (0) | 0.41 |
| Severe | 0 (0) | 0 (0) | 0 (0) | |
| Anxiety | ||||
| Mild | 0 (0) | 1 (12.5) | 2 (28.6) | |
| Moderate | 0 (0) | 0 (0) | 1 (14.3) | 0.23** |
| Severe | 0 (0) | 0 (0) | 0 (0) | |
| Pruritus | ||||
| Mild | 4 (50.0) | 0 (0) | 1 (14.3) | |
| Moderate | 0 (0) | 2 (25.0) | 1 (14.3) | 0.53 |
| Severe | 0 (0) | 0 (0) | 0 (0) | |
| Euphoria, Amnesia, Hallucinations, Nystagmus | ||||
| 0 (0) | 0 (0) | 0 (0) | ||
| Hemodynamic Adverse Effects | ||||
| Hemodynamic AE incidence | ||||
| 3 (37.5) | 3 (37.5) | 2 (28.6) | 0.92 | |
| Systolic Blood pressure | ||||
| < 80 mmHg | 2 (25.0) | 1 (12.5) | 1 (14.3) | 0.78 |
| > 170 mmHg | 0 (0) | 1 (12.5) | 1 (14.3) | 0.68 |
| Heart Rate | ||||
| < 40 bpm | 0 (0) | 2 (25.0) | 0 (0) | 0.70 |
| > 120 bpm | 1 (12.5) | 1 (12.5) | 0 (0) | 0.99 |
Incidences are presented as n (%)
SC subcutaneous, IV intravenous, AE adverse effects
*Chi-squared test
**Chi-squared test, with Yates’ correction