| 1 Repeated need for tranquillisation |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 1.1 need for additional drugs for tranquillisation up to 2 hours |
1 |
60 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.27 [0.10, 0.71] |
| 1.2 need for additional drugs for tranquillisation by 12 hours |
1 |
60 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.88 [0.69, 1.13] |
| 2 Specific behaviour: 1a. Agitation ‐ average scores ‐ i. up to 2 hours |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 2.1 endpoint score at 1 hour (OASS, high=worse) |
1 |
60 |
Mean Difference (IV, Fixed, 95% CI) |
‐8.5 [‐9.93, ‐7.07] |
| 2.2 endpoint score at 2 hours (OASS, high=worse) |
1 |
60 |
Mean Difference (IV, Fixed, 95% CI) |
‐6.7 [‐7.46, ‐5.94] |
| 3 Specific behaviour: 1b. Agitation ‐ average scores ‐ ii. up to 4 hours |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 3.1 endpoint score at 4 hours (OASS, high=worse) |
1 |
60 |
Mean Difference (IV, Fixed, 95% CI) |
‐5.5 [‐6.48, ‐4.52] |
| 4 Specific behaviour: 1c. Agitation ‐ average scores ‐ iii. up to 24 hours |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 4.1 endpoint score at 6 hours (OASS, high=worse) |
1 |
60 |
Mean Difference (IV, Fixed, 95% CI) |
‐3.70 [‐4.56, ‐2.84] |
| 4.2 endpoint score at 12 hours (OASS, high=worse) |
1 |
60 |
Mean Difference (IV, Fixed, 95% CI) |
‐11.2 [‐12.24, ‐10.16] |
| 5 Specific behaviour: 2a. Aggression ‐ average scores ‐ i. up to 2 hours |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 5.1 endpoint score at 1 hour (OAS, high=worse) |
1 |
60 |
Mean Difference (IV, Fixed, 95% CI) |
‐1.20 [‐2.44, 0.04] |
| 5.2 endpoint score at 2 hours (OAS, high=worse) |
1 |
60 |
Mean Difference (IV, Fixed, 95% CI) |
‐2.40 [‐4.21, ‐0.59] |
| 6 Specific behaviour: 2b. Aggression ‐ average scores ‐ ii. up to 4 hours |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 6.1 endpoint score at 4 hours (OAS, high=worse) |
1 |
60 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.10 [‐0.68, 0.48] |
| 7 Specific behaviour: 2c. Aggression ‐ average scores ‐ iii. up to 24 hours |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 7.1 endpoint score at 6 hours (OAS, high=worse) |
1 |
60 |
Mean Difference (IV, Fixed, 95% CI) |
0.40 [0.30, 0.50] |
| 7.2 endpoint score at 12 hours (OAS, high=worse) |
1 |
60 |
Mean Difference (IV, Fixed, 95% CI) |
‐1.9 [‐2.58, ‐1.22] |
| 8 Global outcomes: 1. General ‐ need for additional measures |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 8.1 additional restraint, seclusion or special observation during 12 hours |
1 |
60 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.29 [0.13, 0.61] |
| 9 Adverse effects: 1b. General ‐ one or more adverse events |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 9.1 during 12 hours |
1 |
60 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.73 [0.41, 1.32] |
| 10 Adverse effects: 1a. General ‐ serious |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 10.1 death |
1 |
60 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.0 [0.0, 0.0] |
| 11 Adverse effects: 2a. Specific ‐ arousal ‐ i. various |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 11.1 excessive sedation by 12 hours |
1 |
60 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.25 [0.08, 0.80] |
| 12 Adverse effects: 2b. Specific ‐ arousal ‐ ii. average scores ‐ i. up to 2 hours |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 12.1 endpoint score at 1 hour (RSS, high=worse) |
1 |
60 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.5 [‐1.01, 0.01] |
| 12.2 endpoint score at 2 hours (RSS, high=worse) |
1 |
60 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.10 [‐0.56, 0.36] |
| 13 Adverse effects: 2c. Specific ‐ arousal ‐ ii. average scores ‐ ii. up to 4 hours |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 13.1 endpoint score at 4 hours (RSS, high=worse) |
1 |
60 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.30 [‐0.78, 0.18] |
| 14 Adverse effects: 2d. Specific ‐ arousal ‐ iii. average scores ‐ iii. up to 24 hours |
1 |
|
Mean Difference (IV, Fixed, 95% CI) |
Subtotals only |
| 14.1 endpoint score at 6 hours (RSS, high=worse) |
1 |
60 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.10 [‐0.40, 0.20] |
| 14.2 endpoint score at 12 hours (RSS, high=worse) |
1 |
60 |
Mean Difference (IV, Fixed, 95% CI) |
0.10 [‐0.26, 0.46] |
| 15 Adverse effects: 2e. Specific ‐ cardiovascular |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 15.1 hypotension by 12 hours |
1 |
60 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.09 [0.01, 1.57] |
| 16 Adverse effects: 2f. Specific ‐ movement disorders |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
| 16.1 EPS by 12 hours |
1 |
60 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.67 [0.44, 6.36] |
