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ISRCTN
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ISRCTN29863938
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ClinicalTrials.gov identifier
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Public title
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A randomised controlled trial of intra-muscular Lorazepam versus intra-muscular Haloperidol and Promethazine in the management of psychotic agitations and aggression
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Scientific title
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Acronym
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TREC-INDIA (Tranquilizacao Rapida-Ensaio Clinico; translated from Portuguese - 'Rapid Tranquillisation-Clinical Trial')
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Serial number at source
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N/A
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Study hypothesis
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To compare interventions commonly used for controlling agitation or violence in people with serious psychiatric disorders.
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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India
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Disease/condition/study domain
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Serious mental illnesses combined with overt aggression or agitation
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Participants - inclusion criteria
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Patients need acute intramuscular sedation because of disturbed and dangerous behaviour as decided by the attending physician.
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Participants - exclusion criteria
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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
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Anticipated start date
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01/01/2002
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Anticipated end date
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31/12/2002
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Status of trial
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Completed
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Patient information material
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Target number of participants
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200
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Interventions
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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.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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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.
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Sources of funding
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1. Christian Medical College and Hospital (India) - Fluid Research Grant
2. The Cochrane Schizophrenia Group (CSG) (UK) - supported with funding for sundries
The doctors and nurses of Vellore freely gave support, enthusiasm and skill.
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=15231557&dopt=AbstractPlus
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Contact name
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Dr
Prathap
Tharyan
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Address
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Department of Psychiatry Unit II
Mental Health Center
Christian Medical College
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City/town
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Bagayam Vellore
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Zip/Postcode
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632 002
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Country
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India
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Tel
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+91 (416) 262603 ext 4259
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Fax
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+91 (416) 261632/262268
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Email
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dralexander_in@yahoo.com
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Sponsor
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Christian Medical College and Hospital (India)
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Address
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Bagayam
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City/town
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Vellore
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Zip/Postcode
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632002
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Country
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India
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Sponsor website:
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http://www.cmch-vellore.edu/
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Date applied
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29/04/2002
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Last edited
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02/10/2007
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Date ISRCTN assigned
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29/04/2002
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