Table 2.
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