{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,27]],"date-time":"2026-02-27T05:08:13Z","timestamp":1772168893909,"version":"3.50.1"},"reference-count":46,"publisher":"F1000 Research Ltd","license":[{"start":{"date-parts":[[2019,8,15]],"date-time":"2019-08-15T00:00:00Z","timestamp":1565827200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["f1000research.com"],"crossmark-restriction":false},"short-container-title":["F1000Res"],"abstract":"\n Background:<\/ns3:bold>\n Agitated and aggressive behaviours are common in the psychiatric setting and rapid tranquilisation is sometimes unavoidable. A survey of Lebanese practice has shown that an intramuscular haloperidol, promethazine and chlorpromazine combination is a preferred form of treatment but there are no randomised trials of this triple therapy.\n <\/ns3:p>\n \n Methods:<\/ns3:bold>\n This is a pragmatic randomised trial. Setting - the psychiatric wards of the Psychiatric Hospital of the Cross, Jal Eddib, Lebanon. Participants - any adult patient in the hospital who displays an aggressive episode for whom rapid tranquilisation is unavoidable, who has not been randomised before, for whom there are no known contraindications. Randomisation \u2013 stratified (by ward) randomisation and concealed in closed opaque envelope by independent parties. Procedure \u2013 if the clinical situation arises requiring rapid tranquilisation, medical residents overseeing the patient will open a TREC-Lebanon envelope in which will be notification of which group of treatments should be preferred [Haloperidol + Promethazine + Chlorpromazine (HPC) or Haloperidol + Promethazine (HP)], along with forms for primary, secondary and serious adverse effects. Treatment is not given blindly. Outcome - primary outcome is calm or tranquil at 20 minutes post intervention. Secondary outcomes are calm\/tranquil at 40, 60 and 120 minutes post intervention, asleep, adverse effects, use of straitjacket and leaving the ward. Follow-up will be up to two weeks post randomisation.\n <\/ns3:p>\n \n Discussion:<\/ns3:bold>\n Findings from this study will compare the HPC versus HP combination used in Lebanon\u2019s psychiatry emergency routine practice.\n <\/ns3:p>\n \n Trial registration:<\/ns3:bold>\n ClinicalTrials.gov\n NCT03639558<\/ns3:ext-link>\n . Registration date, August 21, 2018.\n <\/ns3:p>","DOI":"10.12688\/f1000research.19933.1","type":"journal-article","created":{"date-parts":[[2019,8,15]],"date-time":"2019-08-15T09:25:07Z","timestamp":1565861107000},"page":"1442","update-policy":"https:\/\/doi.org\/10.12688\/f1000research.crossmark-policy","source":"Crossref","is-referenced-by-count":2,"title":["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)"],"prefix":"10.12688","volume":"8","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8652-833X","authenticated-orcid":false,"given":"Joseph E.","family":"Dib","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Clive E.","family":"Adams","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Werner Henry","family":"Ikdais","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elie","family":"Atallah","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hiba Edward","family":"Yaacoub","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tony Jean","family":"Merheb","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Francois","family":"Kazour","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fouad","family":"Tahan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Georges","family":"Haddad","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marouan","family":"Zoghbi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jocelyn","family":"Azar","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chadia","family":"Haddad","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6918-5689","authenticated-orcid":false,"given":"Souheil","family":"Hallit","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"2560","published-online":{"date-parts":[[2019,8,15]]},"reference":[{"key":"ref-1","doi-asserted-by":"publisher","first-page":"960-3","DOI":"10.1176\/ajp.142.8.960","article-title":"Assaultive behavior among psychiatric outpatients.","volume":"142","author":"K Tardiff","year":"1985","journal-title":"Am J Psychiatry."},{"key":"ref-2","article-title":"Kaplan and Sadock's synopsis of psychiatry: Behavioral sciences\/clinical psychiatry","author":"H Kaplan","year":"1998"},{"key":"ref-3","first-page":"3-80","article-title":"Treatment of schizophrenia 1999. 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status","group":{"name":"current-referee-status","label":"Current Referee Status"}},{"value":"10.5256\/f1000research.21877.r55715, Sophie Hirsch, Interdisciplinary Section of Neuro-Oncology, Department of Neurology, Hertie Institute for Clinical Brain Research, University Hospital T\u00fcbingen, Eberhard Karls University of T\u00fcbingen, T\u00fcbingen, Germany, 05 Nov 2019, version 1, indexed","URL":"https:\/\/f1000research.com\/articles\/8-1442\/v1#referee-response-55715","order":0,"name":"referee-response-55715","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"Joseph Dib<\/b>; \nPosted: 19 May 2020<\/i>; Hello,On behalf of myself and the TREC-Lebanon team, we would like to thank you for taking the time and responding with valuable input pertaining to the protocol-manuscript.To address your points: while it is true that it would have been better to have the protocol published before recruitment began, the authors (including myself) were on a limited time schedule and had to do with what time we were given. For instance, the resident doctors that were part of the trial team i.e. Administering the intervention, etc would have completed their rotation and left the hospital which would have compromised the study.\nAdding a third active ingredient makes the adverse events and interdependencies even more unclear (e. g. chlorpromazine plus haloperidole and the risk for seizures). Against the background of this discussion and the recent discussion if the tranquilizing effect of a drug combination could also be achieved by a higher dose of one drug as monotherapy, the study design with a two- and a three-drug-combination and even the doses of these combinations left at the discretion of the clinician seems questionable. <\/b>The trial did address the adverse events pertaining to adding a third active ingredient to the haloperidol plus promethazine combination. The protocol does indeed state the doses were at the discretion of the clinicians. However, during the trial itself, the doses were fixed at 5mg Haloperidol, 25mg promethazine and 100mg chlorpromazine.\nConcerning protection of data privacy, it would be interesting how the abbreviations for the patients were built up and which data was exchanged via the Whatsapp group. <\/b>The WhatsApp group allowed updates to trial recruitment as well as open questions pertaining to the trial. Patient names were not used nor were they required since trial numbers were allocated. For instance, if a patient was admitted and randomised, the resident in charge would message the group with "New patient number 14, female". At this point, the trial co-ordinator (Myself) would note the date on the group. This was to keep track on trial recruitment.\n(Note to my "partly" answer on the last question: I missed the sheets that had to be filled in by the doctors. I did not understand why the form "Dr. Stopwatch" and "TREC-Lebanon main data collection form" only were present in the HPC- and not in the HP-envelope.) <\/b>We apologise if this was not as clarified as thought. Both the Dr. Stopwatch form and the main data collection form was present in both the HPC and HP envelope.Once again, we thank you for your time and efforts and hope we have clarified the best we can. We look forward to sharing the trial itself when published.Regards,Joseph Dib","URL":"https:\/\/f1000research.com\/articles\/8-1442\/v1#referee-comment-5520","order":1,"name":"referee-comment-5520","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.5256\/f1000research.21877.r63552, Stefan Leucht, Department of Psychiatry and Psychotherapy, School of Medicine, Technical University of Munich (TUM), Munich, Germany, 19 May 2020, version 1, indexed","URL":"https:\/\/f1000research.com\/articles\/8-1442\/v1#referee-response-63552","order":2,"name":"referee-response-63552","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.5256\/f1000research.21877.r63478, Gisele Huf, National Institute of Quality Control in Health, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil, 29 May 2020, version 1, indexed","URL":"https:\/\/f1000research.com\/articles\/8-1442\/v1#referee-response-63478","order":3,"name":"referee-response-63478","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"The author(s) declared that no grants were involved in supporting this work","order":4,"name":"grant-information","label":"Grant Information"},{"value":"This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.","order":0,"name":"copyright-info","label":"Copyright"}]}}