title: Rapid tranquillisation in psychiatric emergency settings in India: pragmatic randomised controlled trial of intramuscular olanzapine versus intramuscular haloperidol plus promethazine.
abstract: OBJECTIVE
  To compare the effect of intramuscular olanzapine with intramuscular haloperidol plus promethazine on rapid tranquillisation of agitated or violent people with mental illness.
  
  
  METHODS
  Pragmatic, allocation concealed, randomised controlled trial.
  
  
  METHODS
  Emergency services of a general hospital psychiatry department in Vellore, south India.
  
  
  METHODS
  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.
  
  
  METHODS
  Open treatment with intramuscular olanzapine or intramuscular haloperidol plus promethazine.
  
  
  METHODS
  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.
  
  
  BACKGROUND
  Clinical trials NCT00455234 [ClinicalTrials.gov].
authors.affiliation: Department of Psychiatry, Christian Medical College, Vellore, Tamil Nadu, India.
authors.forename: Nirmal S
authors.initials: NS
authors.lastname: Raveendran
authors.forename: Prathap
authors.initials: P
authors.lastname: Tharyan
authors.forename: Jacob
authors.initials: J
authors.lastname: Alexander
authors.forename: Clive Elliot
authors.initials: CE
authors.lastname: Adams
mesh_terms: D000328:Adult; D014150:Antipsychotic Agents / Q000008:administration & dosage*; D001569:Benzodiazepines / Q000008:administration & dosage*; D004338:Drug Combinations; D004637:Emergency Services, Psychiatric; D006220:Haloperidol / Q000008:administration & dosage*; D006801:Humans; D007194:India; D007273:Injections, Intramuscular; D001523:Mental Disorders / Q000188:drug therapy*; D000077152:Olanzapine; D011398:Promethazine / Q000008:administration & dosage*; D011595:Psychomotor Agitation / Q000188:drug therapy*; D016896:Treatment Outcome; D014754:Violence
chemical_list: D014150:Antipsychotic Agents; D004338:Drug Combinations; D001569:Benzodiazepines; D011398:Promethazine; D006220:Haloperidol; D000077152:Olanzapine