Trial reportBMJ (Clinical research ed.)2007
Rapid tranquillisation in psychiatric emergency settings in India: pragmatic randomised controlled trial of intramuscular olanzapine versus intramuscular haloperidol plus promethazine.
Trial report in BMJ (Clinical research ed.), 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00455234 (Rapid Tranquilization of Violent or Agitated People in Psychiatric Emergency Settings- A Pragmatic Randomized Controlled Trial of Intramuscular Olanzepine Vs. Intramuscular Haloperidol + Promethazine.), which is not on this map. Cited by 38 papers, 10 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Rapid Tranquilization of Violent or Agitated People in Psychiatric Emergency Settings- A Pragmatic Randomized Controlled Trial of Intramuscular Olanzepine Vs. Intramuscular Haloperidol + Promethazine.
Who cites it
38 citing papers in PubMed, 10 syntheses or guidelines pooled it, 110 citations in OpenAlex.
- Organisational interventions for preventing and minimising aggression directed towards healthcare workers by patients and patient advocates.The Cochrane database of systematic reviews · 2020Pooled it
- Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) 2018 guidelines for the management of patients with bipolar disorder.Bipolar disorders · 2018Guideline
- Aripiprazole (intramuscular) for psychosis-induced aggression or agitation (rapid tranquillisation).The Cochrane database of systematic reviews · 2018Pooled it
- Haloperidol for psychosis-induced aggression or agitation (rapid tranquillisation).The Cochrane database of systematic reviews · 2017Pooled it
- Droperidol for psychosis-induced aggression or agitation.The Cochrane database of systematic reviews · 2016Pooled it
- Haloperidol plus promethazine for psychosis-induced aggression.The Cochrane database of systematic reviews · 2016Pooled it
- Practical clinical trials in psychopharmacology: a systematic review.Journal of clinical psychopharmacology · 2015Pooled it
- Chlorpromazine for psychosis induced aggression or agitation.The Cochrane database of systematic reviews · 2010Pooled it
- A meta-analysis of the risk of acute extrapyramidal symptoms with intramuscular antipsychotics for the treatment of agitation.The Journal of clinical psychiatry · 2008Pooled it
- Brazilian guidelines for the management of psychomotor agitation. Part 2. Pharmacological approach.Revista brasileira de psiquiatria (Sao Paulo, Brazil : 1999)Pooled it
- Trial
- An observational study on the effects of as-needed use of various antipsychotic drugs for agitation due to psychotic disorders.International clinical psychopharmacology · 2026Observational
- Guideline for pharmacological treatment of schizophrenia 2022.Neuropsychopharmacology reports · 2025Article
- Does the gender of emergency physicians have an impact on the prehospital care of psychiatric emergencies? a retrospective cohort analysis.BMC emergency medicine · 2024Article
- Real-World Data Mining for Signal Detection of Antipsychotics-Associated Adverse Events Using the Korea Adverse Event Reporting System (KAERS) Database.Medicina (Kaunas, Lithuania) · 2024Article
- Effectiveness of pharmacological treatments for severe agitation in real-world emergency settings: protocol of individual-participant-data network meta-analysis.Systematic reviews · 2024Article
- Article
- Absconding among admitted patients with bipolar affective disorder diagnosis in Uganda.BMC psychiatry · 2023Article
- Clinical Practice Guidelines for Assessment and Management of Aggressive and Assaultive Behaviour.Indian journal of psychiatry · 2023Article
- Managing acute agitation and aggression in the world of drug shortages.The mental health clinician · 2021Article
Corrections and comments
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Authors and funding
5 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo compare the effect of intramuscular olanzapine with intramuscular haloperidol plus promethazine on rapid tranquillisation of agitated or violent people with mental illness.
designPragmatic, allocation concealed, randomised controlled trial.
settingEmergency services of a general hospital psychiatry department in Vellore, south India.
participants300 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.
interventionsOpen treatment with intramuscular olanzapine or intramuscular haloperidol plus promethazine.
main outcome measuresPrimary 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.
resultsOf 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.
conclusionsIntramuscular 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 registrationClinical trials NCT00455234 [ClinicalTrials.gov].
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.