Hostname: page-component-586b7cd67f-t7czq Total loading time: 0 Render date: 2024-11-24T14:26:23.579Z Has data issue: false hasContentIssue false

Rapid tranquillisation in a psychiatric emergency hospital in Lebanon: TREC-Lebanon – a pragmatic randomised controlled trial of intramuscular haloperidol and promethazine v. intramuscular haloperidol, promethazine and chlorpromazine

Published online by Cambridge University Press:  06 January 2021

Joseph E. Dib*
Affiliation:
Division of Psychiatry & Applied Psychology, Institute of Mental Health, School of Medicine, University of Nottingham, Nottingham, Nottinghamshire, NG1 1NU, UK
Hiba Edward Yaacoub
Affiliation:
Psychiatric Hospital of the Cross, Deir Salib, Jal l Dib, Lebanon School of Medicine, Lebanese American University, Beirut, Lebanon
Werner Henry Ikdais
Affiliation:
Psychiatric Hospital of the Cross, Deir Salib, Jal l Dib, Lebanon Faculty of Medicine and MedicalSciences, Holy Spirit University of Kaslik (USEK), Beirut, Lebanon
Elie Atallah
Affiliation:
Psychiatric Hospital of the Cross, Deir Salib, Jal l Dib, Lebanon Faculty of Medical Sciences, Lebanese University of Beirut, Beirut, Lebanon
Tony Jean Merheb
Affiliation:
Psychiatric Hospital of the Cross, Deir Salib, Jal l Dib, Lebanon School of Medicine, Lebanese American University, Beirut, Lebanon
Jean Ajaltouni
Affiliation:
Psychiatric Hospital of the Cross, Deir Salib, Jal l Dib, Lebanon Division of Psychiatry, School of Medicine, Lebanese American University, Beirut, Lebanon
Myriam Akkari
Affiliation:
Psychiatric Hospital of the Cross, Deir Salib, Jal l Dib, Lebanon
Marc Mourad
Affiliation:
Psychiatric Hospital of the Cross, Deir Salib, Jal l Dib, Lebanon Faculty of Medicine, St Joseph's University, Beirut, Lebanon
Maria Elias Nasr
Affiliation:
Psychiatric Hospital of the Cross, Deir Salib, Jal l Dib, Lebanon Faculty of Medical Sciences, Lebanese University of Beirut, Beirut, Lebanon
Dory Hachem
Affiliation:
Psychiatric Hospital of the Cross, Deir Salib, Jal l Dib, Lebanon
Francois Kazour
Affiliation:
Psychiatric Hospital of the Cross, Deir Salib, Jal l Dib, Lebanon Faculty of Medical Sciences, Lebanese University of Beirut, Beirut, Lebanon Faculty of Medicine, St Joseph's University, Beirut, Lebanon Department of Psychology, Faculty of Arts and Sciences, Holy Spirit University of Kaslik (USEK), Beirut, Lebanon INSERM U930, équipe 4 “Troubles affectifs”, Université François-Rabelais de Tours, Tours, France
Fouad Tahan
Affiliation:
Psychiatric Hospital of the Cross, Deir Salib, Jal l Dib, Lebanon
Georges Haddad
Affiliation:
Psychiatric Hospital of the Cross, Deir Salib, Jal l Dib, Lebanon School of Medicine, Lebanese American University, Beirut, Lebanon
Jocelyn Azar
Affiliation:
Psychiatric Hospital of the Cross, Deir Salib, Jal l Dib, Lebanon School of Medicine, Lebanese American University, Beirut, Lebanon Faculty of Medical Sciences, Lebanese University of Beirut, Beirut, Lebanon
Marouan Zoghbi
Affiliation:
Psychiatric Hospital of the Cross, Deir Salib, Jal l Dib, Lebanon Faculty of Medicine, St Joseph's University, Beirut, Lebanon
Chadia Haddad
Affiliation:
Psychiatric Hospital of the Cross, Deir Salib, Jal l Dib, Lebanon
Souheil Hallit
Affiliation:
Faculty of Medicine and MedicalSciences, Holy Spirit University of Kaslik (USEK), Beirut, Lebanon INSPECT-LB: Institut National de Sante Publique, Epidemiologie Clinique et Toxicologie, Beirut, Lebanon
Clive E. Adams
Affiliation:
Institute of Mental Health, University of Nottingham, Nottingham, Nottinghamshire, UK.
*
Author for correspondence: Joseph E. Dib, E-mail: [email protected]

Abstract

Background

Agitated patients constitute 10% of all emergency psychiatric treatment. Management guidelines, the preferred treatment of clinicians differ in opinion and practice. In Lebanon, the use of the triple therapy haloperidol plus promethazine plus chlorpromazine (HPC) is frequently used but no studies involving this combination exists.

Method

A pragmatic randomised open trial (September 2018–July 2019) in the Lebanese Psychiatric Hospital of the Cross in Beirut Lebanon involving 100 people requiring urgent intramuscular sedation due to aggressive behaviour were given intramuscular chlorpromazine 100 mg plus haloperidol 5 mg plus promethazine 25 mg (HPC) or intramuscular haloperidol 5 mg plus promethazine 25 mg

Results

Primary outcome data were available for 94 (94%) people. People allocated to the haloperidol plus promethazine (HP) group showed no clear difference at 20 min compared with patients allocated to the HPC group [relative risk (RR) 0.84, 95% confidence interval (CI) 0.47–1.50].

Conclusions

Neither intervention consistently impacted the outcome of ‘calm’, or ‘asleep’ and had no discernible effect on the use of restraints, use of additional drugs or recurrence. If clinicians are faced with uncertainty on which of the two intervention combinations to use, the simpler HP is much more widely tested and the addition of chlorpromazine adds no clear benefit with a risk of additional adverse effects.

Type
Original Article
Copyright
Copyright © The Author(s), 2020. Published by Cambridge University Press

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

Footnotes

*

Souheil Hallit and Clive E Adams are last coauthors.

References

Alexander, J., Tharyan, P., Adams, C., John, T., Mol, C., & Philip, J. (2004). Rapid tranquillisation of violent or agitated patients in a psychiatric emergency setting: Pragmatic randomised trial of intramuscular lorazepam v. haloperidol plus promethazine. British Journal of Psychiatry, 185(1), 6369. doi: 10.1192/bjp.185.1.63CrossRefGoogle ScholarPubMed
Altman, D. G. (1998). Confidence intervals for the number needed to treat. BMJ (Clinical research ed.), 317(7168), 13091312. doi: 10.1136/bmj.317.7168.1309CrossRefGoogle ScholarPubMed
Anderson, C. A., & Bushman, B. J. (2002). Human aggression. Annual Review of Psychology, 53, 2751. doi: 10.1146/annurev.psych.53.100901.135231CrossRefGoogle ScholarPubMed
Berkowitz, L. (1989). Frustration-aggression hypothesis: Examination and reformulation. Psychological Bulletin, 106(1), 59.CrossRefGoogle ScholarPubMed
Bervoets, C., Roelant, E., De Fruyt, J., Demunter, H., Dekeyser, B., Vandenbussche, L., … Morrens, M. (2015). Prescribing preferences in rapid tranquillisation: A survey in Belgian psychiatrists and emergency physicians. BMC Research Notes, 8(1), 218.CrossRefGoogle ScholarPubMed
Binder, R. L., & McNiel, D. E. (1999). Emergency psychiatry: Contemporary practices in managing acutely violent patients in 20 psychiatric emergency rooms. Psychiatric Services, 50(12), 15531554.CrossRefGoogle ScholarPubMed
Brophy, L. M., Roper, C. E., Hamilton, B. E., Tellez, J. J., & McSherry, B. M. (2016). Consumers and carer perspectives on poor practice and the use of seclusion and restraint in mental health settings: Results from Australian focus groups. International Journal of Mental Health Systems, 10, 6. doi: 10.1186/s13033-016-0038-xCrossRefGoogle ScholarPubMed
Busner, J., & Targum, S. D. (2007). The clinical global impressions scale: Applying a research tool in clinical practice. Psychiatry (Edgmont (Pa. : Township)), 4(7), 2837. Retrieved from https://pubmed.ncbi.nlm.nih.gov/20526405, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2880930/Google ScholarPubMed
Cannon, M. E., Sprivulis, P., & McCarthy, J. (2001). Restraint practices in Australasian emergency departments. Australian and New Zealand Journal of Psychiatry, 35(4), 464467. doi: 10.1046/j.1440-1614.2001.00925.xCrossRefGoogle ScholarPubMed
Chanine, L. M., & Chemali, Z. (2009). Mental health care in Lebanon: policy, plans and programmes. EMHJ-Eastern Mediterranean Health Journal, 15(6), 15961612.Google Scholar
Clinical Trials.gov (2018). TREC-Lebanon: A Trial for Rapid Tranquilisation for Agitated Patients in the Emergency Setting (TREC). Retrieved from https://clinicaltrials.gov/ct2/show/NCT03639558.Google Scholar
Cooper, S. J., Browne, F. W., McClean, K. J., & King, D. J. (1983). Aggressive behaviour in a psychiatric observation ward. Acta Psychiatrica Scandinavica, 68(5), 386393.CrossRefGoogle Scholar
Cunnane, J. (1994). Drug management of disturbed behaviour by psychiatrists. Psychiatric Bulletin, 18(3), 138139.CrossRefGoogle Scholar
Dib, J. E. (2020). TREC-Lebanon: Rapid tranquilisation of Aggressive Patients in the Emergency Psychiatry Setting (PhD Psychiatry). University of Nottingham.Google Scholar
Dib, J. E., Adams, C. E., Ikdais, W. H., Atallah, E., Yaacoub, H. E., Merheb, T. J., … Zoghbi, M. (2019). Study protocol for a randomised controlled trial of haloperidol plus promethazine plus chlorpromazine versus haloperidol plus promethazine for rapid tranquilisation for agitated psychiatric patients in the emergency setting (TREC-Lebanon). F1000Research, 8, 1442.CrossRefGoogle Scholar
Dib, J. E., Adams, C. E., Kazour, F., Tahan, F., Haddad, G., Haddad, C., & Hallit, S. (2018). Managing acutely aggressive or agitated people in a psychiatric setting: A survey in Lebanon. Medical Journal of the Islamic Republic of Iran, 32, 60. doi: 10.14196/mjiri.32.60Google ScholarPubMed
Dodge, K. A.. (1991). The structure and function of reactive andproactive aggression. In Pepler, D., & Rubin, k. (Eds.), The Development and Treatment for Childhood Aggression (pp. 201218). Hills-dale: Erlbaum.Google Scholar
Dollard, J., Miller, N. E., Doob, L. W., Mowrer, O. H., & Sears, R. R. (1939). Frustration and aggression.CrossRefGoogle Scholar
Haw, C., Stubbs, J., & Gibbon, S. (2013). A survey of the use of emergency parenteral medication at a secure psychiatric hospital. Journal of Psychiatric Intensive Care, 9(2), 7784.CrossRefGoogle Scholar
Huf, G., Alexander, J., Gandhi, P., & Allen, M. H. (2016). Haloperidol plus promethazine for psychosis-induced aggression. Cochrane Database of Systematic Reviews, 3(11), 1122. 10.1002/14651858.CD005146.pub3.Google Scholar
Huf, G., Coutinho, E., & Adams, C. E. (2007). Rapid tranquillisation in psychiatric emergency settings in Brazil: Pragmatic randomised controlled trial of intramuscular haloperidol versus intramuscular haloperidol plus promethazine. BMJ, 335(7625), 869. doi: 10.1136/bmj.39339.448819.AECrossRefGoogle ScholarPubMed
Huf, G., Coutinho, E. D. S. F., Fagundes, H. M., Oliveira, E. S., Lopez, J. R. R., Gewandszajder, M., … Adams, C. E. (2002). Current practices in managing acutely disturbed patients at three hospitals in Rio de Janeiro-Brazil: A prevalence study. BMC Psychiatry, 2(1), 4.CrossRefGoogle Scholar
IBM Corp (2017). IBM SPSS statistics for windows (version 25.0 ed.). Armonk, NY: IBM Corp.Google Scholar
Jilani, T N, Sabir, S, & Sharma, S. (2020). Trihexyphenidyl. StatPearlsGoogle Scholar
Lepping, P. (2013). The use of emergency psychiatric medication: A survey from 21 countries. Journal of Clinical Psychopharmacology, 33(2), 240242.CrossRefGoogle ScholarPubMed
Migon, M. N., Coutinho, E. S., Huf, G., Adams, C. E., Cunha, G. M., & Allen, M. H. (2008). Factors associated with the use of physical restraints for agitated patients in psychiatric emergency rooms. General Hospital Psychiatry, 30(3), 263268. doi: 10.1016/j.genhosppsych.2007.12.005CrossRefGoogle ScholarPubMed
Moritz, F., Jenvrin, J., Canivet, S., & Gerault, D. (2004). Conduite à tenir devant une agitation aux urgences. Réanimation, 13(8), 500506.CrossRefGoogle Scholar
Nair, S. C., Ibrahim, H., & Celentano, D. D. (2013). Clinical trials in the Middle East and North Africa (MENA) Region: Grandstanding or grandeur? Contemporary Clinical Trials, 36(2), 704710.CrossRefGoogle ScholarPubMed
National Collaborating Centre for Mental Health (2015). Violence and aggression: Short-term management in mental health. London: British Psychological Society.Google Scholar
National Institute of Clinical Excellence (2015). Violence and aggression: Short-term management in mental health, health and community settings (Vol. NG10). London: NICE.Google Scholar
Paton, Carol, Adams, Clive E, Dye, Stephen, Fagan, Elizabeth, Okocha, Chike, & Barnes, Thomas RE. (2019). The pharmacological management of acute behavioural disturbance: Data from a clinical audit conducted in UK mental health services. Journal of Psychopharmacology, 33(4), 472481. http://dx.doi.org/10.1177/0269881118817170.CrossRefGoogle ScholarPubMed
Pilowsky, L. S., Ring, H., Shine, P. J., Battersby, M., & Lader, M. (1992). Rapid tranquillisation. A survey of emergency prescribing in a general psychiatric hospital. British Journal of Psychiatry, 160, 831835.CrossRefGoogle Scholar
Raveendran, N. S., Tharyan, P., Alexander, J., & Adams, C. E. (2007). Rapid tranquillisation in psychiatric emergency settings in India: Pragmatic randomised controlled trial of intramuscular olanzapine versus intramuscular haloperidol plus promethazine. BMJ, 335(7625), 865.CrossRefGoogle ScholarPubMed
Reid, G., & Hughson, M. (2003). Droperidol dropped; consultants not consulted: A survey of the practice of rapid tranquillisation by consultant psychiatrists in the west of Scotland. Psychiatric Bulletin, 27(8), 301304.Google Scholar
Review Manager (2014). Review manager (RevMan) [computer program] (version 5.3.). Copenhagen: The Nordic Cochrane Centre: The Cochrane Collaboration Retrieved from revman.cochrane.org.Google Scholar
Ryan, C., & Bowers, L. (2005). Coercive manoeuvres in a psychiatric intensive care unit. Journal of Psychiatric and Mental Health Nursing, 12(6), 695702.CrossRefGoogle Scholar
TREC Collaborative Group (2003). Rapid tranquillisation for agitated patients in emergency psychiatric rooms: A randomised trial of midazolam versus haloperidol plus promethazine. BMJ, 327(7417), 708713. doi: 10.1136/bmj.327.7417.708CrossRefGoogle Scholar
Vella-Brincat, J, & Macleod, A D. (2004). Haloperidol in palliative care. Palliative medicine, 18(3), 195201CrossRefGoogle ScholarPubMed
Vitiello, B., & Stoff, D. M. (1997). Subtypes of aggression and their relevance to child psychiatry. Journal of the American Academy of Child & Adolescent Psychiatry, 36(3), 307315.CrossRefGoogle ScholarPubMed
Volz, A., Khorsand, V., Gillies, D., & Leucht, S. (2007). Benzodiazepines for schizophrenia. Cochrane Database System Review, 4(1), CD006391. doi: 10.1002/14651858.CD006391.Google Scholar
Yudofsky, S. C., Silver, J. M., Jackson, W., Endicott, J., & Williams, D. (1986). The overt aggression scale for the objective rating of verbal and physical aggression. The American Journal of Psychiatry, 143(1), 3539. https://doi.org/10.1176/ajp.143.1.35.Google ScholarPubMed
Supplementary material: File

Dib et al. supplementary material

Dib et al. supplementary material

Download Dib et al. supplementary material(File)
File 853.5 KB