TREC‐Vellore‐II.
| Methods | Allocation: randomised. Blinding at outcome: none. Duration: 14 days. Data entry: double. Setting: psychiatric unit of medical college, emergency room, open ward | |
| Participants | Diagnosis: schizophrenia (25), mania (188), acute psychosis (30), depression (31), substance misuse (20), other (3) (ICD‐10). N=300. Sex: women 112, men 188. Age: mean ˜ 30.5 years. History: agitation on presentation to emergency room, markedly severely agitated or worse (155), CGI mean ˜ 4.6 (SD ˜ 0.7) | |
| Interventions | 1. Haloperidol IM: dose up to 10 mg stat + promethazine IM: dose up to 50 mg stat. N=150. 2. Olanzapine IM: dose up to 10 mg stat. N=150 | |
| Outcomes | Tranquil or asleep*.
Specific behaviours: other episodes of aggression.
Global state: overall improvement, use of additional medication, use of restraints/seclusion, needing extra visits from the doctor, refusing oral medication, average improvement CGI‐I.
Adverse effects: serious adverse effects, extrapyramidal (BAS, Simpson‐Angus). Service outcomes: no hospital discharge. Leaving the study early. Unable to use ‐ Tranquil or asleep: time to sedation (skewed data) |
|
| Notes | *Primary outcome chosen by emergency room staff | |
| 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: Not clear randomisation |
| 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 | 364 participants selected and 300 randomised, but excluded were explained and follow‐up was 100% at primary outcome and 92% at 2 weeks. Review author judgement: Good follow‐up rate |
| Selective reporting (reporting bias) | Unclear risk | No evidence or information |
| Other bias | Unclear risk | None known |
ACES: Agitation‐Calmness Evaluation Scale BAS: Barnes Akathisia Scale CGI‐I: Clinical Global Impression Improvement ICD‐10: International Classification of Diseases, Tenth Revision IM: intramuscular OAS: Overt Aggression Scale OASS: Overt Agitation Severity Scale PANSS‐EC: Positive and Negative Syndrome Scale ‐ Excited Component RSS: Ramsay Sedation ScaleSD: standard deviation stat: immediately