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Rapid Tranquilization In Psychiatric Emergency: Lorazepam Vs Haloperidol and Promethazine Mix
- sanjeev ranjan, Prabha S. Chandra (25 August 2004)
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What is the evidence for it and how rigorously has it been obtained?
- Muzaffar Husain (3 September 2004)
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Rapid tranquillisation of violent patients
- Om Prakash Jhirwal, P. Kulhara, Debasish Basu (27 April 2005)
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sanjeev ranjan, psychiatrist National Institute of Mental Health and Neurosciences, Bangalore, India, Prabha S. Chandra
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esarsingh{at}yahoo.co.in sanjeev ranjan, et al.
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Dear Editor It is important to develop cost effective and efficient methods of treatment in emergency psychiatry, specially in resource poor settings. Alexander et al (2004) in their article comparing two methods of rapid tranquilization conclude that the injectable haloperidol – promethazine mix is as effective as lorazepam and have also discussed that in India, the former is a more cost effective option. While acknowledging the findings of their study, we would like to make observations regarding the cost effectiveness angle and also a few methodological issues. The preferred combination for rapid tranquilization at the two largest psychiatric centers in India i.e. Bangalore(National Institute of Mental Health and Neurosciences) and Ranchi (Central Institute of Psychiatry)(combined monthly outpatient attendance of > 9000) is that of haloperidol with lorazepam rather than the combination used in the study. This practice is guided by the existing literature as well as existing practice (Mcallister-Williams and Nicol Ferrier, 2002; Hughes and Kleespies, 2003). This combination is about 25% cheaper compared to the combination used in this study (CIMS, 2004). Since promethazine has both alpha-1 and dopaminergic antagonism its combination with haloperidol is more likely to produce hypotension and neuroleptic malignant syndrome in agitated patients who are often dehydrated and dyselectrolytemic. On the other hand use of lorazepam decreases the required dose of haloperidol. We hence feel that the combination used in the study for rapid tranquilization may not be the most cost effective or the most efficacious even in resource poor settings. Regarding the tools used, we feel that use of more aggression specific measures such as the Overt Aggression Scale (Coccaro et al, 1991) which assesses different aspects of aggression and its severity would have generated more specific results, which was not possible with the use of a more global and generic scale such as the CGI. This study also shows that the combination injection produces sedation quicker than intramuscular lorazepam. However This finding should be viewed in the light of following facts. The lorazepam group contained more manic patients, more patients having substance use or already on benzodiazepines (who could have developed tolerance to benzodiazepines), and more patients with marked or severe illness (which would necessitate a higher dose of medication to control). Taken together these factors could contribute significantly to the results. Sanjeev Ranjan Prabha S. Chandra REFERENCES Alexander, J., Tharyan, P., Adams, C. et al. (2004) Rapid tranquilization of violent or agitated patients in a psychiatric emergency setting. British Journal of Psychiatry, 185, 63-69. CIMS (2004) CIMS-Updated prescribers’ handbook. July (update3), 203- 236, Bangalore: Atmedica India. Coccaro, E. F., Harvey, P.D., Kupsaw-Lawrence, E. et al (1991) Development of neuropharmacologically based behavioural assessments of impulsive aggressive behaviour. Journal of Neuropsychiatry and Clinical Neuroscience, 3, s44-51. Hughes, D. H. and Kleespies, P. M. (2003) Treating aggression in the psychiatric emergency service. Journal of Clinical Psychiatry, 64 (suppl. 4), 10-15. McAllister-Williams, R. H, and Nicol Ferrier, I., (2002) Rapid tranquillization: time for a reappraisal of options for parenteral therapy. The British Journal of Psychiatry 180: 485-489. |
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Muzaffar Husain, SHO in Old Age Psychiatry Leeds Mental Health Teaching NHS Trust, UK
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muzhusain{at}hotmail.com Muzaffar Husain
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Research dies without debate, and this letter has been drafted in this vein. Whereas a detailed response to Dr.Ranjan and Dr. Chandra’s critique(1) of Alexander et al’s paper entitled ‘Rapid Tranquillisation of violent or agitated patients in a psychiatric emergency setting’(2) is the prerogative of the authors themselves, I feel I can add a few more points to the ongoing discussion. Contemporary principles of evidence-based mental health care dictate that evidence emanating from systematic reviews of RCT’s and RCT’s ought to have greater bearing on clinical decisions than anecdotal clinical experience reports. A literature search on the topic of ‘rapid tranquillisation’ reveals surprising little research that has ever been done on such a common element of psychiatric practice. McAllister- Williams’ review article (3) (which dates prior to the formation of the TREC Collaborative Group (4)) describes the scarcity of good evidence to suggest any one treatment more than anything else. In fact, there has been only one study cited in that article that had a randomized controlled design (5). This trial compares haloperidol and droperidol, and as droperidol has dropped out of modern practice, it presents outdated evidence. In essence, unless tested within a randomized controlled design, we ought to be wary of clinicians proclaiming evidence for any treatment simply because ‘we use it’, ‘it works’ and ‘we use it on more than 9000 people a month’. On a second point, there is indeed something to say about the simplicity of measures used in Alexander at al’s paper, or indeed even the earlier paper by the TREC Collaboration (4). I feel this adds to the value of these studies, as it brings the trials closer to reality. When the on- call clinician, and when called upon such an instance on the wards, I would personally not quite bother with noting the ‘character’ of patient aggression, violence or agitation. Rapid treatment is precisely that- rapid, and measures have to be taken to de-escalate the situation swiftly and with appropriate care. Furthermore, this debate has acquired new colours in recent years with the introduction and aggressive marketing of expensive atypical antipsychotics for acute agitation and aggression (6). Sponsored studies have surfaced with rapidity claiming evidence to beat all evidence. However, this too much be interpreted with caution as we haven’t tested good old haloperidol and lorazepam enough, and we are being told that IM Olanzapine is the best of all. As the field of psychiatry advances, our role as scientists becomes subsumed in our role as clinicians. This involves critical appraisal and rigorous sifting and researching of evidence before accepting anything on face value. Now the common question dictating any treatment is ‘What is the evidence for it and how rigorously has it been obtained?’ References 1. Ranjan, S. & Chandra, P.,S. (2004) Rapid Tranquillisation in Psychiatric Emergency: Lorazepam vs. Haloperidol-Promethazine Mix. British Journal of Psychiatry Website. 25 August 2004. See link http://bjp.rcpsych.org/cgi/eletters/185/1/63 2. Alexander, J., Tharyan, P., Adams, C., John, T., Mol, C., & Philip, J. (2004) Rapid tranquillisation of violent or agitated patients in a psychiatric setting. British Journal of Psychiatry, 185, 63-69 3. TREC Collaborative Group (2003) Rapid Tranquillisation for agitated patients in emergency psychiatric rooms: a randomized trial of Midazolam vs. Haloperidol plus promethazine. British Medical Journal, 27 September 2003, 708-711 4. McAllister-Williams, R.H. & Ferrier, I. N. (2002) Rapid Tranquillisation: time for reappraisal of options for parenteral therapy. British Journal of Psychiatry, 180, 485-489 5. Resnick, M, Burton B. T. (1984) Droperidol vs. haloperidol in the initial management of acute agitated patients. Journal of Clinical Psychiatry, July; 45(7): 298-299 6. Wright, P., Birkett, M., David, S., R., Meehan, K., et al (2001) Double-Blind, Placebo-Controlled comparison of intramuscular Olanzapine and intramuscular Haloperidol in the treatment of acute agitation in Schizophrenia (2001) American Journal of Psychiatry, 158: (July) 1149-1151 |
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Om Prakash Jhirwal, Senior Resident M.D., P. Kulhara, Debasish Basu
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drjhirwalop{at}yahoo.co.in Om Prakash Jhirwal, et al.
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To the editor, In their excellent paper Alexander et al (2004) systematically conducted comparison trial of intramuscular lorazepam and haloperidol- promethazine in violent or agitated patients. The authors have utilized a prospective follow-up design, used proper diagnostic assessment measures, thus taking care of most of the methodological plans have plagued research in this area. However, a few concerns about the study persists. Ideally, there is a need of a viable placebo arm in order to compare the efficacy of both interventions. A comparison of a new agent against a drug previously shown to be active without a placebo comparator is uninterpretable unless one agent is superior to the others. Concluding that a drug is efficacious without a placebo comparator can lead to an incorrect assumption of efficacy if neither the investigational drug nor the active drug was, in that trial, any better than placebo would have been if included. Introducing a drug into therapeutic use on the basis of such a trial would expose patients to a compound with no greater benefit than placebo (Temple & Ellenberg, 2000). Placebo is also important in the assessment of safety profile, as it provides a base rate for determining which adverse events are truly related to the investigational drug. For these reasons, placebo-controlled trails are almost universally demanded by regulatory bodies to demonstrated efficacy for any pharmacological interventions. The authors have not discussed about investigations to rule out toxic states, epilepsy and other organic conditions. They have failed to comment over vital parameters during and after administration of both interventions. They could have assessed level of satisfaction of treatment team with intervention (Petrack et al.1996). They could also apply any scale on aggression, agitation, alertness and psychopathology (Battaglia et al.1997). Certain issues, however, merit consideration before accepting the authors conclusion. The better outcomes of haloperidol – promethazine group over lorazepam could be possibly due to two reasons. Firstly, combination group had manic patients (i.e. more problematic) than lorazepam group (Table 1, p.65). Secondly, it is evident from the same table that combination group had more moderately ill and less severely ill patients as compared to lorazepam group having less moderately ill and more severely ill. In addition to this, the details of additional medications was not mentioned in the paper. It remains a possibility that some improvement were due to effects of additional medications in both groups. The authors commented that twenty three patients failed to sleep at all during the 4 hour follow-up compared with only eight in the combination group (para 1, p.65) which is different to understand from Table 2 (p.66 ). There were some inconsistent findings in the paper like sleep outcomes in combination group at 120 minutes were 69% and 88% as reflected from Table 2 and Table 5(p.68) respectively. Similarly, there was discrepancy in number of patients in combination group who never tranquil while describing results and in Table 2. Nevertheless, we feel that the authors have taken a useful step in this relatively neglected area. Further studies are required about effectiveness of these interventions in the hope that better understanding can lead to better treatment of violent patients. REFERENCES 1. Alexander, J., Tharyan, P., Adams, C., et al. (2004) Rapid tranquillisation of violent or agitated patients in a psychiatric emergency setting. British Journal of Psychiatry, 185, 63-69. 2. Temple, R & Ellenberg, S. (2000) Placebo-controlled trials and active control trials in the evaluation of new treatment. Part I : ethical and scientific issues. Annals of Internal Medicine, 133, 455-463. 3. Petrack, E.M., Marx, C.M., Wright, M.S. (1996) Intramuscular ketamine is superior to meperidine, promethazine, and chlorpromazine for paediatric emergency department sedation. Archives of Paediatric and Adolescent medicine, 150 (7), 676-681. 4. Battaglia, J., Moss, S., Rush, J., et al. (1997). Haloperidol, lorazepam, or both for psychotic agitation? A multicenter, prospective, double-blind, emergency department study. American Journal of Emergency Medicine, 15(4), 335-340. |
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