7. Design of a future study.
Methods | Allocation: randomised (clearly described). Blinding: single blind (outcomes assessor). Duration: up to 2 weeks. Design: parallel. Setting: emergency settings. |
Participants | Diagnosis: people whose aggressive behaviour is thought due to psychotic illness. N = 300. Age: > 18 years. Sex: not applicable. Inclusion criteria: other measures failed. Exclusion criteria: specific contraindication to evaluated treatments. |
Interventions | 1. Droperidol. N = 150. 2. Drug intervention of choice. N = 150. Both drugs should be known to be effective, but the comparative effectiveness be unclear. |
Outcomes | Tranquil/asleep: binary outcomes, time. Behaviour: need for additional medication, additional aggressive episode. Adverse effects. Acceptability of treatment. Costs: cost of services, cost of care. Quality of life. Service outcomes: days in hospital, discharged, transfer to secure unit. |
Notes | Study should comply with CONSORT and AllTrials. |