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. 2016 Nov 25;2016(11):CD005146. doi: 10.1002/14651858.CD005146.pub3

Comparison 4. HALOPERIDOL + PROMETHAZINE vs ANTIPSYCHOTIC + BENZODIAZEPINE (HALOPERIDOL + MIDAZOLAM).

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
1 Tranquil or asleep: 1. Average sedation score (RSS, high score=good) 1   Mean Difference (IV, Fixed, 95% CI) Subtotals only
1.1 by 1 hour 1 60 Mean Difference (IV, Fixed, 95% CI) ‐0.60 [‐1.13, ‐0.07]
1.2 by 2 hours 1 60 Mean Difference (IV, Fixed, 95% CI) 0.0 [‐0.46, 0.46]
1.3 by 4 hours 1 60 Mean Difference (IV, Fixed, 95% CI) 0.0 [‐0.51, 0.51]
1.4 by 6 hours 1 60 Mean Difference (IV, Fixed, 95% CI) 0.10 [‐0.18, 0.38]
1.5 by 12 hours 1 60 Mean Difference (IV, Fixed, 95% CI) 0.10 [‐0.24, 0.44]
2 Tranquil or asleep: 2. Effect of tranquilisation (PANSS‐EC, high score=bad) (skewed data)     Other data No numeric data
2.1 at 30 minutes     Other data No numeric data
2.2 at 60 minutes     Other data No numeric data
2.3 at 90 minutes     Other data No numeric data
3 Tranquil or asleep: 3. Level of tranquilisation / agitation (ACES) (skewed data)     Other data No numeric data
3.1 at 30 minutes     Other data No numeric data
3.2 at 90 minutes     Other data No numeric data
4 Global state: 1. Needing restraints or seclusion 1 60 Risk Ratio (M‐H, Fixed, 95% CI) 0.24 [0.10, 0.55]
5 Global state: 2. Additional tranquilising drugs 1 57 Risk Ratio (M‐H, Fixed, 95% CI) 1.04 [0.34, 3.19]
6 Global state: 3. Average value of additional medication ‐ after initial dose (skewed data)     Other data No numeric data
7 Adverse effects: 1. Specific ‐ a. Cardiovascular ‐ hypotension 2 117 Risk Ratio (M‐H, Fixed, 95% CI) 0.51 [0.16, 1.58]
8 Adverse effects: 1. Specific ‐ b. Central Nervous System ‐ excessive sedation 2 117 Risk Ratio (M‐H, Fixed, 95% CI) 0.12 [0.03, 0.49]
9 Adverse effects: 1. Specific ‐ c. Extrapyramidal problems ‐ 0‐4 hours 2 117 Risk Ratio (M‐H, Fixed, 95% CI) 1.84 [1.12, 3.02]
10 Specific behaviour: 1. Average aggression score (OAS, high score=bad) 1   Mean Difference (IV, Fixed, 95% CI) Subtotals only
10.1 by 1 hour 1 60 Mean Difference (IV, Fixed, 95% CI) 3.30 [1.35, 5.25]
10.2 by 2 hours 1 60 Mean Difference (IV, Fixed, 95% CI) ‐1.70 [‐3.46, 0.06]
10.3 by 4 hours 1 60 Mean Difference (IV, Fixed, 95% CI) ‐0.70 [‐1.27, ‐0.13]
10.4 by 6 hours 1 60 Mean Difference (IV, Fixed, 95% CI) ‐0.70 [‐0.89, ‐0.51]
10.5 by 12 hours 1 60 Mean Difference (IV, Fixed, 95% CI) ‐3.7 [‐4.39, ‐3.01]
11 Specific behaviour: 2. Average agitation score (OASS, high score=bad) 1   Mean Difference (IV, Fixed, 95% CI) Subtotals only
11.1 by 1 hour 1 60 Mean Difference (IV, Fixed, 95% CI) 16.00 [13.02, 18.98]
11.2 by 2 hours 1 60 Mean Difference (IV, Fixed, 95% CI) 2.70 [1.67, 3.73]
11.3 by 4 hours 1 60 Mean Difference (IV, Fixed, 95% CI) ‐1.70 [‐2.79, ‐0.61]
11.4 by 6 hours 1 60 Mean Difference (IV, Fixed, 95% CI) ‐1.10 [‐2.08, ‐0.12]
11.5 by 12 hours 1 60 Mean Difference (IV, Fixed, 95% CI) ‐10.40 [‐11.47, ‐9.33]
12 Specific behaviour: 3. Severe agitation 1 57 Risk Ratio (M‐H, Fixed, 95% CI) 1.55 [0.28, 8.61]
13 Leaving the study early 2 117 Risk Ratio (M‐H, Fixed, 95% CI) 0.26 [0.03, 2.18]
13.1 by 24 hours 2 117 Risk Ratio (M‐H, Fixed, 95% CI) 0.26 [0.03, 2.18]