A randomised controlled trial of intra-muscular Lorazepam versus intra-muscular Haloperidol and Promethazine in the management of psychotic agitations and aggression

1. Tranquil or asleep by 4 hours
2. The time of onset of tranquillisation and/or sleep

Participants were considered to be tranquil when they were calm and not exhibiting agitated, aggressive or dangerous behaviour. Patients were considered to be asleep if, on inspection, they appeared to be sound asleep and were not aroused by ambient disturbances.

These assessments were conducted only on participants who were awake, as extrapyramidal symptoms are usually not apparent during sleep or, in the case of dystonia or akathisia, are likely to prevent sleep:
1. Clinical Global Impression – Severity (CGI–S) scale at entry
2. CGI–Improvement (CGI–I) scale with respect to aggression and violence
3. Simpson–Angus extrapyramidal side-effects rating scale
4. Barnes Akathisia Scale
5. Any other clinically important adverse effects, especially dystonia

Other outcomes within the first 4 hours were:
6. The use of additional medication for control of agitated or aggressive behaviour
7. The use of physical restraints
8. The need for further medical attention and numbers absconding

Participants were also followed up 2 weeks later to check for adverse effects or adverse outcomes and compliance with oral medication.