Baldacara 2011.
| Methods | Allocation: randomised. Blindness: double blind. Duration: 12 hours. Setting: psychiatric emergency rooms of Santa Casa de Sao Paula in Brazil |
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| Participants | Diagnosis: psychotic disorder (60%), bipolar (40%). N=150. Age: average ˜ 32 years (SD ˜ 8). Sex: 60 women, 90 men. History: agitated people in emergency psychiatric rooms |
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| Interventions | 1. Haloperidol plus promethazine: dose haloperidol 5 mg + promethazine 50 mg. N=30. 2. Olanzapine: dose 10 mg. N=30. 3. Ziprasidone: dose 20 mg. N=30. 4. Haloperidol plus midazolam: dose haloperidol 5 mg + midazolam 15 mg. N=30. 5. Haloperidol: dose 5 mg. N=30 |
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| Outcomes | Tranquil or asleep: average sedation score (RSS). Specific behaviours: aggression, agitation (OAS, OASS). Global state: additional medication, mechanical restraint. Adverse effects: central nervous system, extrapyramidal side effects, hypotension. Leaving the study early. Unable to use ‐ Global state: value of additional medication (skewed data). Economic outcomes: cost of drug (no numerical data) |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: “Randomly assigned under double blinded conditions. Method of randomization employed was allocation by permuted blocks.” Review author judgement: unclear exactly how people were randomised |
| Allocation concealment (selection bias) | Unclear risk | No information regarding concealment |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: “Patients were assessed by two psychiatrists. Psychiatrists were all masked with regard to patient’s treatment assignment, double blinded and study medications were packaged in identical colour‐coded boxes." Review author judgement: Unclear information about participant blinding |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All 150 were allocated and randomised. Review author judgement: People leaving early left before the enrolment and were well‐explained |
| Selective reporting (reporting bias) | Unclear risk | Review author judgement: No evidence of selective reporting |
| Other bias | Unclear risk | No clear evidence of other bias |