TREC‐Vellore‐I.
| Methods | Allocation: randomised. Blinding at outcome: none. Duration: 14 days. Setting: inner‐city emergency rooms of middle‐income country | |
| Participants | Diagnosis: schizophrenia (37), acute psychosis (22), mania (97), depression (19), substance misuse (10), other (15) (ICD‐10). N=200. Sex: women 81, men 119. Age: mean ˜ 31 years (SD ˜ 9). History: agitation on presentation to emergency room, markedly severely agitated or worse (171), CGI mean ˜ 5.1 (SD ˜ 0.7) | |
| Interventions | 1. Haloperidol IM: dose up to 10 mg stat + promethazine IM: dose up to 50 mg stat. N=100. 2. Lorazepam IM: dose up to 4 mg stat. N=100 | |
| Outcomes | Tranquil or asleep*.
Specific behaviours: other episodes of aggression.
Global state: use of additional medication, use of restraints/seclusion, needing extra visits from the doctor, refusing oral medication, overall improvement, average improvement (CGI‐I).
Adverse effects: serious adverse effects, extrapyramidal (BAS, Simpson‐Angus). Service outcomes: no hospital discharge. Leaving the study early |
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| Notes | *Primary outcome chosen by emergency room staff (tranquil or asleep by 4 hours) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Randomization computer generated numbers and block sizes" Review author judgement: Adequate random sequence generation |
| Allocation concealment (selection bias) | Low risk | Quote: "Randomization by computer generated block sizes, prepared consequently numbered cardboard boxes identical in weight and appearance". Review author judgement: Adequate concealment |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No evidence of participant blinding |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "After assignment, rating was not blind as the management had to know the prescription medication". Review author judgement: No outcome blinding |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 221 participants selected and 200 randomised, but excluded were explained and follow‐up was 100% after 4 hours. Review author judgement: Good follow‐up rate |
| Selective reporting (reporting bias) | Unclear risk | No evidence or information |
| Other bias | Unclear risk | None known |