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Rapid Tranquillisation of Violent Or Agitated Patients in a Psychiatric

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Rapid Tranquillisation of Violent Or Agitated Patients in a Psychiatric BRITISH JOURNAL OF PSYCHIATRY (2004), 185, 63^69 Rapid tranquillisation of violent or agitated patients Department of Psychiatry at the Christian Medical College, in Vellore in the southern in a psychiatric emergency setting Indian state of Tamil Nadu. The majority of patients presenting to the psychiatric emergency services of this 1800-bed teach- Pragmatic randomised trial of intramuscular lorazepam v. ing hospital were accompanied by family haloperidol plus promethazine members and were either brought directly, or were referred by general practitioners in the town or adjoining towns and villages JACOB ALEXANDER, PRATHAP THARYAN, CLIVE ADAMS, THOMAS JOHN, and from emergency services of this and CARINA MOL and JONCY PHILIP other hospitals. Background The pharmacological Violent or aggressive behaviour is a Patient selection management of violence in people with common reason for emergency psychiatric presentations, with assaultive behaviour Consecutive patients were assessed and psychiatric disordersis under-researched. seen in 3–10% of psychiatric patients were eligible for trial entry if the attending physician felt that intramuscular sedation Aims To compare interventions (Tardiff & Sweillam, 1982; Tardiff & Koenigsberg, 1985). A haloperidol– was clearly indicated because of agitation, commonly used for controlling agitation or promethazine mix is commonly used for aggression or violent behaviour, and if the violence in people with serious psychiatric rapid tranquillisation of agitated or violent physician did not feel that either one of disorders.disorders. patients in India and Brazil (Huf et aletal,, the interventions posed an additional risk 20022002aa). Promethazine is an antihistamine for the patient. In keeping with prevailing MethodMethod Werandomised 200 peopleto that adds to the sedative effect of haloperi- clinical practice in this country, consent receive intramuscularlorazepam (4 mg) dol and prevents acute dystonic reactions was obtained from a responsible relative if patients refused, or lacked capacity to con- or intramuscular haloperidol (10 mg) plus otherwise common with the intramuscular use of haloperidol (Van Harten et aletal,, sent to treatment by virtue of severe mental promethazine (25^50 mg mix). 1999). As a haloperidol–promethazine illness. For this trial relatives were fully informed and their written consent ResultsResults At blinded assessments 4 h mix had not been evaluated previously in the context of a randomised trial, two prag- obtained; patients without a responsible later (99.5% follow-up), equalnumbersin matic trials were designed by the Tranquili- relative were excluded. This trial compared both groups (96%) were tranquiltranquilor or zazaccaoˇcc¸a˜oRa Rapida-Ensaio´pida-Ensaio ClıClınic´nic TREC two low-risk interventions in common use, asleep.However, 76% given the Collaborative Group to assess this combi- the relative benefits of which are unknown. The institutional research and ethics haloperidol^promethazine mix were nation against intramuscular benzodiaze- committee approved the trial design, the asleep comparedwith 45% ofthose pines. One trial was conducted in Rio de Janeiro (TREC–Rio) and the other in India consent procedure and the form used. allocatedlorazepam (RR 2.29,95% CICI2.29,95% ¼ (TREC–India). Here we present results of 1.59^3.39;NNT¼3.2,95% CI 2.3^5.4).The TREC–India and comment briefly on those Sample size haloperidol^promethazine mix produced of TREC–Rio. Intramuscular lorazepam is From the existing literature, with tranquilli- a faster onset of tranquillisation/sedation used increasingly to handle psychiatric sation of 73% of people given benzodiaze- emergencies in India, costs the same as the and more clinical improvement over the pines and 57% given typical antipsychotics haloperidol–promethazine combination first 2 h.Neither intervention differed (Battaglia(Battaglia et aletal, 1997; JoyJoy,1997; et aletal, 2003), with (£0.17) and offers the advantage of produ- a power of 80% at 95% confidence significantly in the need for additional cing no dystonic or extrapyramidal adverse intervals and an expected precision of intervention or physicalrestraints, effects; however, its efficacy in relation to 20%, the minimum sample size required numbers absconding, or adverse effects. the antipsychotic–antihistamine combina- was 90 people per arm. tion is unclear. TREC–India was a pragma- Conclusions Both interventions are tic randomised trial undertaken in real- Randomisation and interventions effective for controlling violent/agitated worldworldconditionsconditions comparing an intra- muscular combination of haloperidol plus Eligible patients were randomised to behaviour.If speed of sedationis required, promethazine v.v. intramuscular lorazepam. receive either intramuscular haloperidol the haloperidol^promethazinehaloperidol ^ promethazine (10 mg) and promethazine (25 or 50 mg) combination has advantages over mixed in the same syringe, or intramuscular lorazepam.lorazepam. METHOD lorazepam (4 mg). All doses were at the discretion of the attending doctor, although Declaration of interest None.None. SettingSetting the recommended dose was 10 mg halo- This pragmatic randomised controlled trial, peridol plus 50 mg promethazine, or 4 mg designed to include patients typical of those lorazepam. These doses were arrived at by presenting to emergency services and to prevailing clinical practice and a pilot study interfere little with routine practice, was that showed that at least 4 mg lorazepam conducted in the emergency services of the was required to achieve a similar degree 6363 Downloaded from https://www.cambridge.org/core. 28 Sep 2021 at 05:26:29, subject to the Cambridge Core terms of use. ALEXANDER ET AL of tranquillisation as the haloperidol– asleep; in addition, the time of onset of follow-up points entered as a covariate. We promethazine mix. tranquillisation and sleep were noted. Parti- used the Mann–Whitney UU-test to compare Randomisation was according to a cipants were considered to be tranquil mean times to tranquillisation and sedation computer-generated random numbers list when they were calm and not exhibiting in the two groups, as the data did not have in varying sized blocks of less than 10 pre- agitated, aggressive or dangerous behav- a normal distribution. The kappa statistic pared by the UK collaborator. This iour. They were considered to be asleep if, was used to evaluate agreement between collaborator worked with a member of on inspection, they appeared to be sound the blinded guesses of the coordinators the TREC–India team who had no clinical asleep and were not aroused by ambient regarding treatment allocation. responsibilities in conducting the trial. The disturbances; the depth of this apparent team member and a pharmacist prepared slumber was not assessed further. They consecutively numbered opaque cardboard were also rated on the Clinical Global RESULTSRESULTS boxes, identical in appearance and weight, Impression – Severity (CGI–S) scale at on the outside of which was a form with entry, and the CGI–Improvement (CGI–I) A total of 221 patients presented to the questions to be completed by the attending scale (Guy, 1976) with respect to aggres- emergency services with disruptive behav- doctor while ‘blind’ to the contents of the sion and violence, the Simpson–Angus iour over a 5-month period in 2002. box. The boxes contained haloperidol extrapyramidal side-effects rating scale Twenty-one people could not be included (5 mg(5mg662 ampoules) plus promethazine (Simpson & Angus, 1970) and the Barnes in the trial for reasons outlined in the (50 mg(50mg661 ampoule) or lorazepam Akathisia Scale (Barnes, 1989) at each CONSORT diagram (Fig. 1). The remain- (4 mg(4mg661 ampoule), as determined by the assessment point; any other clinically im- ing 200 patients were randomised. The randomisation list, one disposable syringe portant adverse effect, especially dystonia, follow-up rate for the primary outcome at and needle and study follow-up forms. All was also noted. These assessments were 4 h was 100% for those given lorazepam those involved clinically in the study had conducted only on participants who were and 99% for the antipsychotic–antihistamine no indication of what medicines were in awake, as extrapyramidal symptoms are combination. Follow-up rates for second- the boxes until they were opened. usually not apparent during sleep or, in ary outcomes and at 2 weeks were 92% the case of dystonia or akathisia, are likely for those allocated to lorazepam and Procedure to prevent sleep. Other outcomes within the 90% for people given the antipsychotic– Once eligibility of a patient was ensured, first 4 h were the use of additional medi- antihistamine combination. the next consecutive box was taken from cation for control of agitated or aggressive All patients allocated to the lorazepam the emergency cupboard and this consti- behaviour, the use of physical restraints, arm received 4 mg of the drug and everyone tuted randomisation. The duty doctor the need for further medical attention and randomised to haloperidol–promethazine recorded the severity of the episode and numbers absconding. Participants were also received 10 mg of haloperidol combined the initial diagnosis on the form stuck to followed up 2 weeks later to check for with 50 mg (96/100) or 25 mg (4/100) the outside of the sealed intervention pack. adverse effects or adverse outcomes and promethazine. The box was then opened and the interven- compliance with oral medication. The Most patients were
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