Haloperidol plus promethazine for psychosis‐induced aggression

Gisele Huf; Jacob Alexander; Michael H Allen; Nirmal S Raveendran

doi:10.1002/14651858.CD005146

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Analysis 1.1

Comparison 1 HALOPERIDOL + PROMETHAZINE vs BENZODIAZEPINES, Outcome 1 Tranquil or asleep: 1. Not tranquil or asleep.

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Study	Intervention	Mean (mins)	SD	N	Statistical test	p
TREC‐Vellore‐I	Haloperidol + promethazine	29.7	35.6	100	Mann‐Whitney U 327.0	<0.001
TREC‐Vellore‐I	Lorazepam	47.8	46.7	100

Analysis 1.2

Comparison 1 HALOPERIDOL + PROMETHAZINE vs BENZODIAZEPINES, Outcome 2 Tranquil or asleep: 2. Time until tranquil or asleep.

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Analysis 1.3

Comparison 1 HALOPERIDOL + PROMETHAZINE vs BENZODIAZEPINES, Outcome 3 Tranquil or asleep: 3. Not asleep.

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Study	Intervention	Mean (mins)	SD	N	Statistical test	p
TREC‐Vellore‐I	Haloperidol + promethazine	37.4	42.9	100	Mann‐Whitney U 1893.5	<0.001
TREC‐Vellore‐I	Lorazepam	80.6	64.3	100

Analysis 1.4

Comparison 1 HALOPERIDOL + PROMETHAZINE vs BENZODIAZEPINES, Outcome 4 Tranquil or asleep: 4. Time until asleep.

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Analysis 1.5

Comparison 1 HALOPERIDOL + PROMETHAZINE vs BENZODIAZEPINES, Outcome 5 Adverse effects: 1. Serious adverse effect.

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Analysis 1.6

Comparison 1 HALOPERIDOL + PROMETHAZINE vs BENZODIAZEPINES, Outcome 6 Adverse effects: 2. Extrapyramidal problems ‐ 0‐4 hours.

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Analysis 1.7

Comparison 1 HALOPERIDOL + PROMETHAZINE vs BENZODIAZEPINES, Outcome 7 Global effect: 1. Additional tranquillising drugs.

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Analysis 1.8

Comparison 1 HALOPERIDOL + PROMETHAZINE vs BENZODIAZEPINES, Outcome 8 Global effect: 2. Not clinically improved.

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Analysis 1.9

Comparison 1 HALOPERIDOL + PROMETHAZINE vs BENZODIAZEPINES, Outcome 9 Global effect: 3. Average improvement (CGI).

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Analysis 1.10

Comparison 1 HALOPERIDOL + PROMETHAZINE vs BENZODIAZEPINES, Outcome 10 Global effect: 4. Needing restraints or seclusion.

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Analysis 1.11

Comparison 1 HALOPERIDOL + PROMETHAZINE vs BENZODIAZEPINES, Outcome 11 Global effect: 5. Other episode of aggression ‐ within 24 hours.

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Analysis 1.12

Comparison 1 HALOPERIDOL + PROMETHAZINE vs BENZODIAZEPINES, Outcome 12 Global effect: 6. Doctor called to see patient.

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Analysis 1.13

Comparison 1 HALOPERIDOL + PROMETHAZINE vs BENZODIAZEPINES, Outcome 13 Global effect: 7. Refusing oral medication.

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Analysis 1.14

Comparison 1 HALOPERIDOL + PROMETHAZINE vs BENZODIAZEPINES, Outcome 14 Service outcomes: Not discharged.

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Analysis 1.15

Comparison 1 HALOPERIDOL + PROMETHAZINE vs BENZODIAZEPINES, Outcome 15 Leaving the study early.

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Analysis 2.1

Comparison 2 HALOPERIDOL + PROMETHAZINE vs HALOPERIDOL, Outcome 1 Tranquil or asleep: 1. Not tranquil or asleep.

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Analysis 2.2

Comparison 2 HALOPERIDOL + PROMETHAZINE vs HALOPERIDOL, Outcome 2 Tranquil or asleep: 3. Not asleep.

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Analysis 2.3

Comparison 2 HALOPERIDOL + PROMETHAZINE vs HALOPERIDOL, Outcome 3 Adverse effects: 1. Any serious adverse effect.

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Analysis 2.4

Comparison 2 HALOPERIDOL + PROMETHAZINE vs HALOPERIDOL, Outcome 4 Adverse effects: 2. Acute dystonia.

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Analysis 2.5

Comparison 2 HALOPERIDOL + PROMETHAZINE vs HALOPERIDOL, Outcome 5 Adverse effects: 3. Seizure.

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Analysis 2.7

Comparison 2 HALOPERIDOL + PROMETHAZINE vs HALOPERIDOL, Outcome 7 Global effect: 1. Additional tranquillising drugs.

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Analysis 2.10

Comparison 2 HALOPERIDOL + PROMETHAZINE vs HALOPERIDOL, Outcome 10 Global effect: 4. Needing restraints or seclusion.

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Analysis 2.11

Comparison 2 HALOPERIDOL + PROMETHAZINE vs HALOPERIDOL, Outcome 11 Global effect: 5. Other episode of aggression ‐ within 24 hours.

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Analysis 2.12

Comparison 2 HALOPERIDOL + PROMETHAZINE vs HALOPERIDOL, Outcome 12 Global effect: 6. Doctor called to see patient.

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Analysis 2.13

Comparison 2 HALOPERIDOL + PROMETHAZINE vs HALOPERIDOL, Outcome 13 Global effect: 7. Refusing oral medication.

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Analysis 2.14

Comparison 2 HALOPERIDOL + PROMETHAZINE vs HALOPERIDOL, Outcome 14 Service outcomes: Not discharged.

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Analysis 2.15

Comparison 2 HALOPERIDOL + PROMETHAZINE vs HALOPERIDOL, Outcome 15 Leaving the study early.

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Analysis 3.1

Comparison 3 HALOPERIDOL + PROMETHAZINE vs OLANZAPINE, Outcome 1 Tranquil or asleep: 1. Not tranquil or asleep.

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Study	Intervention	Mean (mins)	SD	N	Statistical test	p
TREC‐Vellore‐II	Haloperidol + Promethazine	12.8	16.7	150	Mann‐Whitney U	0.4
TREC‐Vellore‐II	Olanzapine	20.5	34.5	150

Analysis 3.2

Comparison 3 HALOPERIDOL + PROMETHAZINE vs OLANZAPINE, Outcome 2 Tranquil or asleep: 2. Time until tranquil or asleep.

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Analysis 3.3

Comparison 3 HALOPERIDOL + PROMETHAZINE vs OLANZAPINE, Outcome 3 Tranquil or asleep: 3. Not asleep.

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Study	Intervention	Mean (mins)	SD	N	Statistical test	p
TREC‐Vellore‐II	Haloperidol + Promethazine	26.2	32.2	150	Mann‐Whitney U	0.2
TREC‐Vellore‐II	Olanzapine	34.9	42.2	150

Analysis 3.4

Comparison 3 HALOPERIDOL + PROMETHAZINE vs OLANZAPINE, Outcome 4 Tranquil or asleep: 4. Time until asleep.

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Analysis 3.5

Comparison 3 HALOPERIDOL + PROMETHAZINE vs OLANZAPINE, Outcome 5 Tranquil or asleep: 5. Never tranquil or asleep during first 4 hrs.

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Analysis 3.6

Comparison 3 HALOPERIDOL + PROMETHAZINE vs OLANZAPINE, Outcome 6 Adverse effects: 1. Serious adverse effect.

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Analysis 3.7

Comparison 3 HALOPERIDOL + PROMETHAZINE vs OLANZAPINE, Outcome 7 Adverse effects: 2. Extrapyramidal problems ‐ 0‐4 hours.

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Analysis 3.8

Comparison 3 HALOPERIDOL + PROMETHAZINE vs OLANZAPINE, Outcome 8 Global effect: 1. Requiring additional drugs during initial phase.

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Analysis 3.9

Comparison 3 HALOPERIDOL + PROMETHAZINE vs OLANZAPINE, Outcome 9 Global effect: 2. Not clinically improved.

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Analysis 3.10

Comparison 3 HALOPERIDOL + PROMETHAZINE vs OLANZAPINE, Outcome 10 Global effect: 3. Average improvement (CGI).

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Analysis 3.11

Comparison 3 HALOPERIDOL + PROMETHAZINE vs OLANZAPINE, Outcome 11 Global effect: 4. Needing restraints or seclusion.

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Analysis 3.12

Comparison 3 HALOPERIDOL + PROMETHAZINE vs OLANZAPINE, Outcome 12 Global effect: 5. Further observation after 4 hours.

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Analysis 3.13

Comparison 3 HALOPERIDOL + PROMETHAZINE vs OLANZAPINE, Outcome 13 Global effect: 6. Doctor called to see patient.

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Analysis 3.14

Comparison 3 HALOPERIDOL + PROMETHAZINE vs OLANZAPINE, Outcome 14 Global effect: 7. Taking oral drugs at 2 weeks.

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Analysis 3.15

Comparison 3 HALOPERIDOL + PROMETHAZINE vs OLANZAPINE, Outcome 15 Service outcomes: 1. Not discharged.

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Analysis 3.16

Comparison 3 HALOPERIDOL + PROMETHAZINE vs OLANZAPINE, Outcome 16 Service outcomes: 2. Admitted.

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Analysis 3.17

Comparison 3 HALOPERIDOL + PROMETHAZINE vs OLANZAPINE, Outcome 17 Leaving the study early.

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Table 1. Survey of rapid tranquillisation in Rio de Janeiro 2002

Drug of choice	Frequency of use	mean mg (range)
Haloperidol + promethazine	61%	5 (2.5‐10) + 50 (25‐100)
Haloperidol + promethazine + diazepam	15%	5 (2.5‐10) + 50 (25‐100) + 10
Diazepam	9%	10
Haloperidol + promethazine + chlorpromazine	7%	5 + 50 + 25
Chlorpromazine + diazepam + promethazine	1%	25 + 10 + 50
Chlorpromazine + promethazine	1%	25 + 50
Chlorpromazine	1%	25
Diazepam + promethazine	1%	10 + 50
Haloperidol + diazepam	1%	5 + 10
Promethazine	1%	50

Table 1. Survey of rapid tranquillisation in Rio de Janeiro 2002

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Comparison 1. HALOPERIDOL + PROMETHAZINE vs BENZODIAZEPINES

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Tranquil or asleep: 1. Not tranquil or asleep Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

1.1 by 30 minutes	2		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
1.2 by 1 hour	2		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
1.3 by 2 hours	2		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
1.4 by 4 hours	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
2 Tranquil or asleep: 2. Time until tranquil or asleep Show forest plot			Other data	No numeric data

3 Tranquil or asleep: 3. Not asleep Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

3.1 by 30 minutes	2		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.2 by 1 hour	2		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.3 by 2 hours	2		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.4 by 4 hours	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4 Tranquil or asleep: 4. Time until asleep Show forest plot			Other data	No numeric data

5 Adverse effects: 1. Serious adverse effect Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

5.1 by 30 minutes	2	501	Risk Ratio (M‐H, Fixed, 95% CI)	0.60 [0.08, 4.52]
5.2 by 1 hour	2	501	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
5.3 by 2 hours	2	501	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
5.4 by 4 hours	1	200	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
6 Adverse effects: 2. Extrapyramidal problems ‐ 0‐4 hours Show forest plot	1		Risk Difference (M‐H, Fixed, 95% CI)	Subtotals only

6.1 akathisia (Barnes Akathisia Scale)	1	200	Risk Difference (M‐H, Fixed, 95% CI)	0.0 [‐0.02, 0.02]
6.2 any change in scale‐rated extrapyramidal problems (Simpson & Angus Scale)	1	200	Risk Difference (M‐H, Fixed, 95% CI)	0.0 [‐0.02, 0.02]
7 Global effect: 1. Additional tranquillising drugs Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

7.1 by 30 minutes	1	200	Risk Ratio (M‐H, Fixed, 95% CI)	0.33 [0.01, 8.09]
7.2 by 1 hour	1	200	Risk Ratio (M‐H, Fixed, 95% CI)	0.33 [0.04, 3.15]
7.3 by 2 hours	2	501	Risk Ratio (M‐H, Fixed, 95% CI)	1.67 [0.62, 4.54]
7.4 by 4 hours	1	200	Risk Ratio (M‐H, Fixed, 95% CI)	0.89 [0.36, 2.21]
8 Global effect: 2. Not clinically improved Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

8.1 by 30 minutes	1	200	Risk Ratio (M‐H, Fixed, 95% CI)	0.40 [0.25, 0.66]
8.2 by 1 hour	1	200	Risk Ratio (M‐H, Fixed, 95% CI)	0.5 [0.32, 0.79]
8.3 by 2 hours	1	200	Risk Ratio (M‐H, Fixed, 95% CI)	0.46 [0.25, 0.86]
8.4 by 4 hours	1	200	Risk Ratio (M‐H, Fixed, 95% CI)	0.93 [0.46, 1.87]
9 Global effect: 3. Average improvement (CGI) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

9.1 by 30 minutes	1	200	Mean Difference (IV, Fixed, 95% CI)	‐0.60 [‐0.86, ‐0.34]
9.2 by 1 hour	1	200	Mean Difference (IV, Fixed, 95% CI)	‐0.33 [‐0.54, ‐0.12]
9.3 by 2 hours	1	200	Mean Difference (IV, Fixed, 95% CI)	‐0.23 [‐0.51, 0.05]
9.4 by 4 hours	1	200	Mean Difference (IV, Fixed, 95% CI)	‐0.09 [‐0.32, 0.14]
10 Global effect: 4. Needing restraints or seclusion Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

10.1 by 30 minutes	1	200	Risk Ratio (M‐H, Fixed, 95% CI)	0.55 [0.28, 1.09]
10.2 by 1 hour	1	200	Risk Ratio (M‐H, Fixed, 95% CI)	0.56 [0.27, 1.14]
10.3 by 2 hours	2	501	Risk Ratio (M‐H, Fixed, 95% CI)	1.09 [0.77, 1.56]
10.4 by 4 hours	1	200	Risk Ratio (M‐H, Fixed, 95% CI)	0.82 [0.35, 1.89]
11 Global effect: 5. Other episode of aggression ‐ within 24 hours Show forest plot	1	301	Risk Ratio (M‐H, Fixed, 95% CI)	0.89 [0.62, 1.29]

12 Global effect: 6. Doctor called to see patient Show forest plot	2	501	Risk Ratio (M‐H, Fixed, 95% CI)	0.82 [0.60, 1.10]

12.1 within 4 hours	1	200	Risk Ratio (M‐H, Fixed, 95% CI)	0.72 [0.37, 1.39]
12.2 within 24 hours	1	301	Risk Ratio (M‐H, Fixed, 95% CI)	0.85 [0.61, 1.19]
13 Global effect: 7. Refusing oral medication Show forest plot	2	501	Risk Ratio (M‐H, Fixed, 95% CI)	1.00 [0.59, 1.72]

13.1 within 24 hours	1	301	Risk Ratio (M‐H, Fixed, 95% CI)	0.69 [0.33, 1.44]
13.2 within 2 weeks	1	200	Risk Ratio (M‐H, Fixed, 95% CI)	1.63 [0.70, 3.75]
14 Service outcomes: Not discharged Show forest plot	2	501	Risk Ratio (M‐H, Fixed, 95% CI)	1.08 [0.91, 1.28]

14.1 by 4 hours	1	200	Risk Ratio (M‐H, Fixed, 95% CI)	1.13 [0.85, 1.50]
14.2 by 15 days	1	301	Risk Ratio (M‐H, Fixed, 95% CI)	1.05 [0.84, 1.29]
15 Leaving the study early Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

15.1 by 2 hours	1	301	Risk Ratio (M‐H, Fixed, 95% CI)	2.01 [0.18, 21.97]
15.2 by 4 hours	1	200	Risk Ratio (M‐H, Fixed, 95% CI)	3.0 [0.12, 72.77]
15.3 by 24 hours	1	301	Risk Ratio (M‐H, Fixed, 95% CI)	1.01 [0.36, 2.80]
15.4 by 2 weeks	2	501	Risk Ratio (M‐H, Fixed, 95% CI)	0.91 [0.41, 2.05]

Comparison 1. HALOPERIDOL + PROMETHAZINE vs BENZODIAZEPINES

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Comparison 2. HALOPERIDOL + PROMETHAZINE vs HALOPERIDOL

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Tranquil or asleep: 1. Not tranquil or asleep Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.1 by 20 minutes	1	316	Risk Ratio (M‐H, Fixed, 95% CI)	0.65 [0.49, 0.87]
1.2 by 40 mins	1	316	Risk Ratio (M‐H, Fixed, 95% CI)	0.83 [0.56, 1.24]
1.3 by 1 hour	1	316	Risk Ratio (M‐H, Fixed, 95% CI)	0.75 [0.46, 1.23]
1.4 by 2 hours	1	316	Risk Ratio (M‐H, Fixed, 95% CI)	0.55 [0.32, 0.96]
2 Tranquil or asleep: 3. Not asleep Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

2.1 by 20 minutes	1	316	Risk Ratio (M‐H, Fixed, 95% CI)	0.89 [0.82, 0.96]
2.2 by 40 minutes	1	316	Risk Ratio (M‐H, Fixed, 95% CI)	0.99 [0.85, 1.16]
2.3 by 1 hour	1	316	Risk Ratio (M‐H, Fixed, 95% CI)	1.04 [0.84, 1.28]
2.4 by 2 hours	1	316	Risk Ratio (M‐H, Fixed, 95% CI)	1.01 [0.77, 1.31]
3 Adverse effects: 1. Any serious adverse effect Show forest plot	1	298	Risk Ratio (M‐H, Fixed, 95% CI)	0.09 [0.01, 0.66]

3.1 by 24 hours	1	298	Risk Ratio (M‐H, Fixed, 95% CI)	0.09 [0.01, 0.66]
4 Adverse effects: 2. Acute dystonia Show forest plot	1	298	Risk Ratio (M‐H, Fixed, 95% CI)	0.05 [0.00, 0.76]

4.1 by 24 hours	1	298	Risk Ratio (M‐H, Fixed, 95% CI)	0.05 [0.00, 0.76]
5 Adverse effects: 3. Seizure Show forest plot	1	298	Risk Ratio (M‐H, Fixed, 95% CI)	0.95 [0.06, 15.01]

5.1 by 24 hours	1	298	Risk Ratio (M‐H, Fixed, 95% CI)	0.95 [0.06, 15.01]
7 Global effect: 1. Additional tranquillising drugs Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

7.1 by 2 hours	1	311	Risk Ratio (M‐H, Fixed, 95% CI)	0.45 [0.16, 1.25]
10 Global effect: 4. Needing restraints or seclusion Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

10.1 by 2 hours	1	311	Risk Ratio (M‐H, Fixed, 95% CI)	0.80 [0.54, 1.18]
11 Global effect: 5. Other episode of aggression ‐ within 24 hours Show forest plot	1	298	Risk Ratio (M‐H, Fixed, 95% CI)	1.17 [0.68, 2.01]

12 Global effect: 6. Doctor called to see patient Show forest plot	1	298	Risk Ratio (M‐H, Fixed, 95% CI)	0.66 [0.44, 0.99]

12.1 within 24 hours	1	298	Risk Ratio (M‐H, Fixed, 95% CI)	0.66 [0.44, 0.99]
13 Global effect: 7. Refusing oral medication Show forest plot	1	294	Risk Ratio (M‐H, Fixed, 95% CI)	1.03 [0.54, 1.97]

13.1 within 24 hours	1	294	Risk Ratio (M‐H, Fixed, 95% CI)	1.03 [0.54, 1.97]
14 Service outcomes: Not discharged Show forest plot	1	310	Risk Ratio (M‐H, Fixed, 95% CI)	0.83 [0.64, 1.07]

14.1 by 2 weeks	1	310	Risk Ratio (M‐H, Fixed, 95% CI)	0.83 [0.64, 1.07]
15 Leaving the study early Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

15.1 before treatment	1	316	Risk Ratio (M‐H, Fixed, 95% CI)	1.46 [0.25, 8.63]
15.2 by 24 hours	1	316	Risk Ratio (M‐H, Fixed, 95% CI)	0.89 [0.41, 1.97]
15.3 by 2 weeks	1	316	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.20, 4.76]

Comparison 2. HALOPERIDOL + PROMETHAZINE vs HALOPERIDOL

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Comparison 3. HALOPERIDOL + PROMETHAZINE vs OLANZAPINE

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Tranquil or asleep: 1. Not tranquil or asleep Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.1 by 15 mins	1	300	Risk Ratio (M‐H, Fixed, 95% CI)	0.74 [0.38, 1.41]
1.2 by 30 minutes	1	300	Risk Ratio (M‐H, Fixed, 95% CI)	0.6 [0.22, 1.61]
1.3 by 1 hour	1	300	Risk Ratio (M‐H, Fixed, 95% CI)	0.11 [0.01, 0.87]
1.4 by 2 hours	1	300	Risk Ratio (M‐H, Fixed, 95% CI)	0.44 [0.14, 1.41]
1.5 by 4 hours	1	300	Risk Ratio (M‐H, Fixed, 95% CI)	0.83 [0.26, 2.67]
2 Tranquil or asleep: 2. Time until tranquil or asleep Show forest plot			Other data	No numeric data

3 Tranquil or asleep: 3. Not asleep Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

3.1 by 15 mins	1	300	Risk Ratio (M‐H, Fixed, 95% CI)	0.75 [0.60, 0.95]
3.2 by 30 minutes	1	300	Risk Ratio (M‐H, Fixed, 95% CI)	0.65 [0.46, 0.93]
3.3 by 1 hour	1	300	Risk Ratio (M‐H, Fixed, 95% CI)	0.59 [0.40, 0.87]
3.4 by 2 hours	1	300	Risk Ratio (M‐H, Fixed, 95% CI)	0.24 [0.14, 0.41]
3.5 by 4 hours	1	300	Risk Ratio (M‐H, Fixed, 95% CI)	0.61 [0.44, 0.86]
4 Tranquil or asleep: 4. Time until asleep Show forest plot			Other data	No numeric data

5 Tranquil or asleep: 5. Never tranquil or asleep during first 4 hrs Show forest plot	1	300	Risk Ratio (M‐H, Fixed, 95% CI)	0.25 [0.03, 2.21]

6 Adverse effects: 1. Serious adverse effect Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

6.1 by 4 hours	1	300	Risk Ratio (M‐H, Fixed, 95% CI)	0.33 [0.04, 3.17]
6.2 at 2 weeks	1	300	Risk Ratio (M‐H, Fixed, 95% CI)	0.33 [0.01, 8.12]
7 Adverse effects: 2. Extrapyramidal problems ‐ 0‐4 hours Show forest plot	1		Risk Difference (M‐H, Fixed, 95% CI)	Subtotals only

7.1 any change in scale‐rated extrapyramidal problems (Simpson & Angus Scale)	1	300	Risk Difference (M‐H, Fixed, 95% CI)	0.0 [‐0.01, 0.01]
8 Global effect: 1. Requiring additional drugs during initial phase Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

8.1 by 4 hours	1	300	Risk Ratio (M‐H, Fixed, 95% CI)	0.48 [0.33, 0.69]
9 Global effect: 2. Not clinically improved Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

9.1 by 15 mins	1	300	Risk Ratio (M‐H, Fixed, 95% CI)	0.79 [0.56, 1.11]
9.2 by 30 minutes	1	300	Risk Ratio (M‐H, Fixed, 95% CI)	0.58 [0.36, 0.91]
9.3 by 1 hour	1	300	Risk Ratio (M‐H, Fixed, 95% CI)	0.4 [0.21, 0.75]
9.4 by 2 hours	1	300	Risk Ratio (M‐H, Fixed, 95% CI)	0.44 [0.24, 0.79]
9.5 by 4 hours	1	300	Risk Ratio (M‐H, Fixed, 95% CI)	0.47 [0.22, 1.01]
10 Global effect: 3. Average improvement (CGI) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

10.1 by 15 mins	1	300	Mean Difference (IV, Fixed, 95% CI)	‐0.28 [‐0.51, ‐0.05]
10.2 by 30 minutes	1	300	Mean Difference (IV, Fixed, 95% CI)	‐0.35 [‐0.58, ‐0.12]
10.3 by 1 hour	1	300	Mean Difference (IV, Fixed, 95% CI)	‐0.41 [‐0.60, ‐0.22]
10.4 by 2 hours	1	300	Mean Difference (IV, Fixed, 95% CI)	‐0.36 [‐0.56, ‐0.16]
10.5 by 4 hours	1	300	Mean Difference (IV, Fixed, 95% CI)	‐0.27 [‐0.43, ‐0.11]
11 Global effect: 4. Needing restraints or seclusion Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

11.1 by 15 mins	1	300	Risk Ratio (M‐H, Fixed, 95% CI)	0.96 [0.67, 1.36]
11.2 by 30 minutes	1	300	Risk Ratio (M‐H, Fixed, 95% CI)	1.02 [0.71, 1.47]
11.3 by 1 hour	1	300	Risk Ratio (M‐H, Fixed, 95% CI)	0.97 [0.66, 1.44]
11.4 by 2 hours	1	300	Risk Ratio (M‐H, Fixed, 95% CI)	0.79 [0.51, 1.25]
11.5 by 4 hours	1	300	Risk Ratio (M‐H, Fixed, 95% CI)	0.63 [0.34, 1.14]
12 Global effect: 5. Further observation after 4 hours Show forest plot	1	300	Risk Ratio (M‐H, Fixed, 95% CI)	1.17 [0.80, 1.71]

13 Global effect: 6. Doctor called to see patient Show forest plot	1	300	Risk Ratio (M‐H, Fixed, 95% CI)	0.47 [0.30, 0.73]

13.1 within 4 hours	1	300	Risk Ratio (M‐H, Fixed, 95% CI)	0.47 [0.30, 0.73]
14 Global effect: 7. Taking oral drugs at 2 weeks Show forest plot	1	300	Risk Ratio (M‐H, Fixed, 95% CI)	0.96 [0.89, 1.04]

15 Service outcomes: 1. Not discharged Show forest plot	1	300	Risk Ratio (M‐H, Fixed, 95% CI)	0.94 [0.77, 1.16]

15.1 after 4 hours	1	300	Risk Ratio (M‐H, Fixed, 95% CI)	0.94 [0.77, 1.16]
16 Service outcomes: 2. Admitted Show forest plot	1	300	Risk Ratio (M‐H, Fixed, 95% CI)	0.81 [0.56, 1.16]

16.1 after 4 hours	1	300	Risk Ratio (M‐H, Fixed, 95% CI)	0.81 [0.56, 1.16]
17 Leaving the study early Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

17.1 by 15 mins	1	300	Risk Ratio (M‐H, Fixed, 95% CI)	0.33 [0.01, 8.12]
17.2 by 30 mins	1	300	Risk Ratio (M‐H, Fixed, 95% CI)	0.33 [0.01, 8.12]
17.3 by 60 mins	1	300	Risk Ratio (M‐H, Fixed, 95% CI)	0.33 [0.01, 8.12]
17.4 by 120 mins	1	300	Risk Ratio (M‐H, Fixed, 95% CI)	0.14 [0.01, 2.74]
17.5 by 240 mins	1	300	Risk Ratio (M‐H, Fixed, 95% CI)	0.09 [0.01, 1.63]
17.6 by 2 weeks	1	300	Risk Ratio (M‐H, Fixed, 95% CI)	0.71 [0.33, 1.56]

Comparison 3. HALOPERIDOL + PROMETHAZINE vs OLANZAPINE

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