Serious mental illnesses combined with overt aggression or agitation Mental and Behavioural Disorders Overt aggression or agitation
Conditions
Interventions
1. Haloperidol (up to 10 mg IM) with promethazine (up to 50 mg IM)
2. Lorazepam (4 mg IM)
Doses are not fixed and are at the discretion of the attending doctors.
Sponsors
Christian Medical College and Hospital (India)
Eligibility
Inclusion criteria
Inclusion criteria: Patients need acute intramuscular sedation because of disturbed and dangerous behaviour as decided by the attending physician.
Exclusion criteria
Exclusion criteria: 1. The clinician believes that one of the two treatments represents an additional risk for the patient 2. Feels that one of the two treatments is definitely indicated for a given patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
India
Outcome results
None listed