A randomised controlled trial of intra-muscular Lorazepam versus intra-muscular Haloperidol and Promethazine in the management of psychotic agitations and aggression
| ISRCTN | ISRCTN29863938 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29863938 |
| Secondary identifying numbers | N/A |
- Submission date
- 29/04/2002
- Registration date
- 29/04/2002
- Last edited
- 02/10/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Prathap Tharyan
Scientific
Scientific
Department of Psychiatry Unit II
Mental Health Center
Christian Medical College
Bagayam Vellore
632 002
India
| Phone | +91 (416) 262603 ext 4259 |
|---|---|
| dralexander_in@yahoo.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | TREC-INDIA (Tranquilizacao Rapida-Ensaio Clinico; translated from Portuguese - 'Rapid Tranquillisation-Clinical Trial') |
| Study objectives | To compare interventions commonly used for controlling agitation or violence in people with serious psychiatric disorders. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Serious mental illnesses combined with overt aggression or agitation |
| Intervention | 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Lorazepam, Haloperidol, Promethazine |
| Primary outcome measure | 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 outcome measures | 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 (CGIS) scale at entry 2. CGIImprovement (CGII) scale with respect to aggression and violence 3. SimpsonAngus 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. |
| Overall study start date | 01/01/2002 |
| Completion date | 31/12/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 200 |
| Key inclusion criteria | Patients need acute intramuscular sedation because of disturbed and dangerous behaviour as decided by the attending physician. |
| Key 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 |
| Date of first enrolment | 01/01/2002 |
| Date of final enrolment | 31/12/2002 |
Locations
Countries of recruitment
- India
Study participating centre
Department of Psychiatry Unit II
Bagayam Vellore
632 002
India
632 002
India
Sponsor information
Christian Medical College and Hospital (India)
Hospital/treatment centre
Hospital/treatment centre
Bagayam
Vellore
632002
India
| Website | http://www.cmch-vellore.edu/ |
|---|---|
"ROR" |
https://ror.org/00c7kvd80 |
Funders
Funder type
Hospital/treatment centre
Christian Medical College and Hospital (India) - Fluid Research Grant
No information available
The Cochrane Schizophrenia Group (CSG) (UK) - supported with funding for sundries
No information available
The doctors and nurses of Vellore freely gave support, enthusiasm and skill.
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/07/2004 | Yes | No |
