Trial reportBMJ (Clinical research ed.)2003
Rapid tranquillisation for agitated patients in emergency psychiatric rooms: a randomised trial of midazolam versus haloperidol plus promethazine.
Trial report in BMJ (Clinical research ed.), 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03554915 (Ketamine Versus Midazolam for Prehospital Agitation), which is not on this map. Cited by 50 papers, 12 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.
Ketamine Versus Midazolam for Prehospital Agitation
Who cites it
50 citing papers in PubMed, 12 syntheses or guidelines pooled it.
- Organisational interventions for preventing and minimising aggression directed towards healthcare workers by patients and patient advocates.The Cochrane database of systematic reviews · 2020Pooled it
- Rapid Tranquilization for Psychiatric Patients with Psychomotor Agitation: What is Known About it?The Psychiatric quarterly · 2017Pooled 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
- Intermittent drug techniques for schizophrenia.The Cochrane database of systematic reviews · 2013Pooled it
- Benzodiazepines for schizophrenia.The Cochrane database of systematic reviews · 2012Pooled 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
- Olanzapine IM or velotab for acutely disturbed/agitated people with suspected serious mental illnesses.The Cochrane database of systematic reviews · 2005Pooled it
- Clotiapine for acute psychotic illnesses.The Cochrane database of systematic reviews · 2004Pooled it
- Brazilian guidelines for the management of psychomotor agitation. Part 2. Pharmacological approach.Revista brasileira de psiquiatria (Sao Paulo, Brazil : 1999)Pooled it
- Trial
- Effectiveness of second-generation antipsychotics: a naturalistic, randomized comparison of olanzapine, quetiapine, risperidone, and ziprasidone.BMC psychiatry · 2010Trial
- Use of antipsychotics and benzodiazepines in patients with psychiatric emergencies: results of an observational trial.BMC psychiatry · 2008Trial
- Rapid tranquillisation in psychiatric emergency settings in Brazil: pragmatic randomised controlled trial of intramuscular haloperidol versus intramuscular haloperidol plus promethazine.BMJ (Clinical research ed.) · 2007Trial
- Rapid tranquillisation in psychiatric emergency settings in India: pragmatic randomised controlled trial of intramuscular olanzapine versus intramuscular haloperidol plus promethazine.BMJ (Clinical research ed.) · 2007Trial
- An observational study on the effects of as-needed use of various antipsychotic drugs for agitation due to psychotic disorders.International clinical psychopharmacology · 2026Observational
- Midazolam versus midazolam-promethazine combination for oral sedation in third molar surgery: A randomized split-mouth trial.Medicina oral, patologia oral y cirugia bucal · 2026Article
- Chronotherapeutic considerations of benzodiazepine administration for agitation management in the emergency department.BMJ mental health · 2025Review
Corrections and comments
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Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo compare two widely used drug treatments for people with aggression or agitation due to mental illness.
designPragmatic, randomised clinical trial.
settingThree psychiatric emergency rooms in Rio de Janeiro, Brazil. SUBJECTS: 301 aggressive or agitated people.
interventionsOpen treatment with intramuscular midazolam or intramuscular haloperidol plus promethazine.
main outcome measuresPatients tranquil or sedated at 20 minutes. SECONDARY OUTCOMES: patients tranquil or asleep by 40, 60, and 120 minutes; restrained or given extra drugs within 2 hours; severe adverse events; another episode of agitation or aggression; needing extra visits from doctor during first 24 hours; overall antipsychotic load in first 24 hours; and not discharged by two weeks.
results151 patients were randomised to midazolam, and 150 to haloperidol-promethazine mix. Follow up for the primary outcome was available for 298 (99%): 134/151 (89%) of patients given midazolam were tranquil or asleep after 20 minutes compared with 101/150 (67%) of those given haloperidol plus promethazine (relative risk 1.32 (95% confidence interval 1.16 to 1.49)). By 40 minutes, midazolam still had a statistically and clinically significant 13% relative advantage (1.13 (1.01 to 1.26)). After 1 hour, about 90% of both groups were tranquil or asleep. One important adverse event occurred in each group: a patient given midazolam had transient respiratory depression, and one given haloperidol-promethazine had a grande mal seizure.
conclusionsBoth treatments were effective. Midazolam was more rapidly sedating than haloperidol-promethazine, reducing the time people are exposed to aggression. Adverse effects and resources to deal with them should be considered in the choice of the treatment.
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