Lorazepam 1997b, USA.
Study characteristics | ||
Methods | Allocation: randomised. Blinding: double blind. Design: not stated. Duration: 4 hours. Setting: Psychiatric Emergency Service, Eastern Pennsylvania Psychiatric Institute, US. |
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Participants | Diagnosis: schizophrenia (n = 13), bipolar (n = 13), schizoaffective (n = 4), psychotic disorder not otherwise specified (n = 7). n = 37. Age: 18‐61 years. Gender: 26 men, 11 women. Ethnicity: white (n = 21), African‐American (n = 14), Hispanic (n = 2). Consent: need for informed consent waived. History: drug abuse or dependence n = 10. Inclusion criteria: highly agitated people exhibiting psychotic symptoms, judged by emergency department staff to be an imminent danger to themselves, required restraint, scored ≥ 5 on ≥ 3 BPRS items and ≥ 4 on CGI. Exclusion criteria: not stated. |
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Interventions | Benzodiazepines vs antipsychotics. 1. Lorazepam 2 mg oral or IM (n = 17). 2. Haloperidol 5 mg oral or IM (n = 20). Medication administered every 30 minutes for 4 hours 'as needed' until the participant was sedated or no longer posed a danger to themselves or staff. |
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Outcomes | Global impression: sedation; mean endpoint score (CGI‐S). Mental state: mean endpoint score (BPRS). Adverse effects/events: EPS. |
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Notes | More bipolar participants received lorazepam (n = 10) than haloperidol (n = 3). | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomised; however, no further description of randomisation provided. |
Allocation concealment (selection bias) | Unclear risk | Not stated. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Double blind; however, no further description of blinding provided. Rating scales: symptom ratings were conducted by 1 of 4 raters (psychiatry residents or psychiatric nursing staff). Raters were trained by trial author SF. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Follow‐up: 100%. |
Selective reporting (reporting bias) | Low risk | All measure outcomes were reported. |
Other bias | Low risk | Funding: supported in part by a grant from the National Alliance for Research on Schizophrenia and Depression. We detect no other bias. |