BMJ  2007;335:865 (27 October), doi:10.1136/bmj.39341.608519.BE (published 22 October 2007)

Research

Rapid tranquillisation in psychiatric emergency settings in India: pragmatic randomised controlled trial of intramuscular olanzapine versus intramuscular haloperidol plus promethazine

Nirmal S Raveendran, lecturer1, Prathap Tharyan, professor2, Jacob Alexander, lecturer1, Clive Elliot Adams, associate professor3, TREC-India II Collaborative Group

1 Department of Psychiatry, Christian Medical College, Vellore, 2 Department of Psychiatry, Christian Medical College, Vellore, and BV Moses Centre for Clinical Trials and Evidence Based Medicine, Christian Medical College, Vellore 632002, Tamil Nadu, India, 3 Division of Psychiatry, University of Nottingham

Correspondence to: P Tharyan prathap{at}cmcvellore.ac.in

Objective To compare the effect of intramuscular olanzapine with intramuscular haloperidol plus promethazine on rapid tranquillisation of agitated or violent people with mental illness.

Design Pragmatic, allocation concealed, randomised controlled trial.

Setting Emergency services of a general hospital psychiatry department in Vellore, south India.

Participants 300 adults with agitated or violent behaviour as a result of mental illness; 150 randomised to intramuscular olanzapine and 150 randomised to intramuscular haloperidol plus promethazine.

Interventions Open treatment with intramuscular olanzapine or intramuscular haloperidol plus promethazine.

Main outcome measures Primary outcome was proportion of patients who were tranquil or asleep at 15 minutes and 240 minutes. Secondary outcomes were proportion of patients who were tranquil, asleep, restrained, absconding, or clinically improved at 15, 30, 60, 120, and 240 minutes; additional medical interventions and adverse effects over four hours; and compliance with oral drugs and adverse effects over two weeks.

Results Of 300 people randomised to receive either intramuscular olanzapine or intramuscular haloperidol plus promethazine, follow-up data were available for primary outcomes for 298 (99%). Both treatments resulted in similar proportions of people being tranquil or asleep at 15 minutes (olanzapine 131/150 (87%), haloperidol plus promethazine 136/150 (91%); relative risk 0.96, 95% confidence interval 0.34 to 1.47) and 240 minutes (olanzapine 144/150 (96%), haloperidol plus promethazine 145/150 (97%); relative risk 0.99, 0.95 to 1.03). However, more people given olanzapine than those given haloperidol plus promethazine required additional drugs over four hours (65/150 (43%) v 31/150 (21%); relative risk 2.07, 1.43 to 2.97). Adverse effects were uncommon with both treatments.

Conclusions Intramuscular olanzapine and intramuscular haloperidol plus promethazine were effective at rapidly tranquillising or sedating agitated or violent patients with mental illness but the combination resulted in fewer additional medical interventions within four hours of intervention.

Trial registration Clinical trials NCT00455234 [ClinicalTrials.gov] .


Add to CiteULike CiteULike   Add to Complore Complore   Add to Connotea Connotea   Add to Del.icio.us Del.icio.us   Add to Digg Digg   Add to Reddit Reddit   Add to Technorati Technorati    What's this?

Relevant Articles

Make health inequality history
Trish Groves
BMJ 2007 335: 0. [Extract] [Full Text]

Rapid tranquillisation in emergency psychiatric settings
Chittaranjan Andrade
BMJ 2007 335: 835-836. [Extract] [Full Text] [PDF]

Rapid tranquillisation for agitated patients in emergency psychiatric rooms: a randomised trial of midazolam versus haloperidol plus promethazine
BMJ 2003 327: 708-713. [Abstract] [Full Text] [PDF]

Systematic reviews in health care: Assessing the quality of controlled clinical trials
Peter Jüni, Douglas G Altman, and Matthias Egger
BMJ 2001 323: 42-46. [Extract] [Full Text] [PDF]

Fortnightly review: Acute dystonia induced by drug treatment
Peter N van Harten, Hans W Hoek, and Rene S Kahn
BMJ 1999 319: 623-626. [Extract] [Full Text] [PDF]

This article has been cited by other articles:

  • Stroup, T. S., Geddes, J. R. (2008). Randomized Controlled Trials for Schizophrenia: Study Designs Targeted to Distinct Goals. Schizophr Bull 34: 266-274 [Abstract] [Full text]  
  • Adams, C. E., Coutinho, E. S. F., Davis, J., Duggan, L., Leucht, S., Li, C., Tharyan, P. (2008). Cochrane Schizophrenia Group. Schizophr Bull 34: 259-265 [Full text]  
  • (2007). Acute Sedation of Violent Psychiatric Patients. JWatch Emergency Med. 2007: 2-2 [Full text]  
  • Andrade, C. (2007). Rapid tranquillisation in emergency psychiatric settings. BMJ 335: 835-836 [Full text]  

Rapid Responses:

Read all Rapid Responses

Rapid tranquilization should remain a last resort treatment.
Martina Onajite Esisi
bmj.com, 29 Oct 2007 [Full text]
More clarification!
Raghuthaman Gopal
bmj.com, 31 Oct 2007 [Full text]
What do we need from Rapid Tranquillisation
Premraj Muthuvelu
bmj.com, 2 Nov 2007 [Full text]
Rapid tranquilisation with olanzapine versus haloperidol-promethazine: Some queries
Himanshu Gupta, et al.
bmj.com, 5 Dec 2007 [Full text]
Doc2Doc Vacancy
Access jobs at BMJ Careers
Whats new online at Student BMJ