Van Leeuwen 1977.
| Methods | Allocation: randomly assigned ‐ participants listed in chronological order assigned individually numbered vials. Blinding: double ‐ no further details. Design: double‐blind placebo‐controlled study. Duration: 30 minutes. Settings: not clear. |
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| Participants | Diagnosis: schizophrenia (N = 20); mania/manic depression (N = 9), confusional state (N = 2), miscellaneous (N = 3), not recorded (N = 7). N = 41. Age: range 14 to 78 years, median 33.5 years. Sex: female 18, male 23. History: acutely agitated, about 50% already taking maintenance psychotropic drugs, about 20% already received inadequate treatment for agitation. Excluded: no exclusions mentioned. |
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| Interventions | 1. Droperidol 10 mg IV. N = 19. 2. Placebo 10 mg IV. N = 22. |
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| Outcomes | Global state: needing additional injection, time to control (no measure/scale given). Adverse effects. |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "The vials containing this solution were individually numbered and their content (droperidol or placebo) was randomly assigned". Response: probably randomised. |
| Allocation concealment (selection bias) | Unclear risk | Quote: "On entering the trial, the patients were chronologically numbered and this number indicated the vial which was to be used". Response: unclear method of concealment. |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "the study was strictly double blinded..." Response: participants and personnel were probably blind to the intervention. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No mention of blinding of outcome assessment. |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote: "breaking the code revealed that 19 patients had been treated with droperidol and 22 patients with placebo". Response: all participants who were initially included were analysed. |
| Selective reporting (reporting bias) | Low risk | All outcomes were reported. |
BPRS: Brief Psychiatric Rating Scale; ECG: electrocardiogram; ED: emergency department; EPS: extrapyramidal adverse effects; IM: intramuscular; IV: intravenous; SAT: Social Attribution Task.