Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2026-02-23 @ 1:53 PM
Study NCT ID:
NCT03639558
Status:
COMPLETED
Last Update Posted:
2022-06-14
First Post:
2018-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
TREC-Lebanon: A Trial for Rapid Tranquilisation for Agitated Patients in the Emergency Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000374', 'term': 'Aggression'}, {'id': 'D011595', 'term': 'Psychomotor Agitation'}], 'ancestors': [{'id': 'D000096762', 'term': 'Aberrant Motor Behavior in Dementia'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011596', 'term': 'Psychomotor Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006220', 'term': 'Haloperidol'}, {'id': 'D011398', 'term': 'Promethazine'}, {'id': 'D002746', 'term': 'Chlorpromazine'}], 'ancestors': [{'id': 'D002090', 'term': 'Butyrophenones'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010640', 'term': 'Phenothiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'joseph.elie.dib@gmail.com', 'phone': '07748668553', 'title': 'Dr. Joseph Dib', 'organization': 'University of Nottingham/Psychiatric Hospital of the Cross'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Possible limitations for this trial are that there are no Emergency Departments; therefore residents must always carry the TREC envelopes at all times, increasing the risk for error (i.e. misplacing envelope, using wrong envelope, etc.). Despite the limitation, the chances of error remain low due to the small sample size of 100.'}}, 'adverseEventsModule': {'timeFrame': '10 months from time of intervention.', 'description': 'No change of definitions pertaining to adverse events. No further relevant information to be provided.', 'eventGroups': [{'id': 'EG000', 'title': 'Haloperidol + Promethazine + Chlorpromazine', 'description': 'Haloperidol + Promethazine + Chlorpromazine: This is the usual treatment given by this hospital during an aggressive psychiatric episode.', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 0, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Haloperidol + Promethazine', 'description': 'Haloperidol + Promethazine: This is the second most used psycho-pharmacological combination used in this hospital during an aggressive psychiatric episode.', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 0, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants According to the Time Taken for Aggressive Behaviour to Change to Calm and Tranquil', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Haloperidol + Promethazine + Chlorpromazine', 'description': 'Haloperidol + Promethazine + Chlorpromazine: This is the usual treatment given by this hospital during an aggressive psychiatric episode.'}, {'id': 'OG001', 'title': 'Haloperidol + Promethazine', 'description': 'Haloperidol + Promethazine: This is the second most used psycho-pharmacological combination used in this hospital during an aggressive psychiatric episode.'}], 'classes': [{'title': 'Calm or tranquil at 20 minutes', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Calm or tranquil at 40 minutes', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Calm or tranquil at 60 minutes', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'Calm or tranquil at 120 minutes', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '20, 40, 60 and 120 minutes post intervention treatment', 'description': 'Patient no longer exhibiting aggressive behavior both verbal and physical post intervention treatment. A primary measure of outcome form will contain a Calm or Tranquil column followed by four rows: 20 mins, 40 mins, 60 mins and 120 mins post intervention medication. The boxes would be ticked depending if the patient meets the primary measure of outcome within the time frame provided.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time Taken for Patient to Fall Asleep Post Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Haloperidol + Promethazine + Chlorpromazine', 'description': 'Haloperidol + Promethazine + Chlorpromazine: This is the usual treatment given by this hospital during an aggressive psychiatric episode.'}, {'id': 'OG001', 'title': 'Haloperidol + Promethazine', 'description': 'Haloperidol + Promethazine: This is the second most used psycho-pharmacological combination used in this hospital during an aggressive psychiatric episode.'}], 'classes': [{'title': 'Asleep at 20 minutes', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Asleep at 40 minutes', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Asleep at 60 minutes', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Asleep at 120 minutes', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '20, 40, 60 and 120 minutes post intervention treatment', 'description': 'Patient has fallen asleep and is no longer aggressive post intervention treatment and will be noted on the outcomes form which includes a checklist of different time intervals: 20, 40, 60 and 120 minutes post intervention treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time Patient Was Placed in Straitjacket/Restraint Post Intervention Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Haloperidol + Promethazine + Chlorpromazine', 'description': 'Haloperidol + Promethazine + Chlorpromazine: This is the usual treatment given by this hospital during an aggressive psychiatric episode.'}, {'id': 'OG001', 'title': 'Haloperidol + Promethazine', 'description': 'Haloperidol + Promethazine: This is the second most used psycho-pharmacological combination used in this hospital during an aggressive psychiatric episode.'}], 'classes': [{'title': 'Restraints at 20 minutes', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Restraints at 40 minutes', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Restraints at 60 minutes', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Restraints at 120 minutes', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '20, 40, 60 and 120 minutes post intervention treatment', 'description': 'If patient was placed in a straitjacket post intervention due to aggression - this would be noted on the outcomes form which includes a checklist at certain time intervals 20,40,60 and 120 minutes post intervention treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time Noted Where Important Adverse Effects Occurred Post Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Haloperidol + Promethazine + Chlorpromazine', 'description': 'Haloperidol + Promethazine + Chlorpromazine: This is the usual treatment given by this hospital during an aggressive psychiatric episode.'}, {'id': 'OG001', 'title': 'Haloperidol + Promethazine', 'description': 'Haloperidol + Promethazine: This is the second most used psycho-pharmacological combination used in this hospital during an aggressive psychiatric episode.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '20, 40, 60 and 120 minutes post intervention treatment', 'description': 'If patient exhibits any adverse effects post intervention treatment, this will be noted within the time frames.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Total number of participants who were analysed for adverse effects post intervention. No patients exhibited adverse effects in this study.'}, {'type': 'SECONDARY', 'title': 'Time Patient Left the Ward Against Medical Advice During the Time Period After the Intervention Was Administered.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Haloperidol + Promethazine + Chlorpromazine', 'description': 'Haloperidol + Promethazine + Chlorpromazine: This is the usual treatment given by this hospital during an aggressive psychiatric episode.'}, {'id': 'OG001', 'title': 'Haloperidol + Promethazine', 'description': 'Haloperidol + Promethazine: This is the second most used psycho-pharmacological combination used in this hospital during an aggressive psychiatric episode.'}], 'timeFrame': '20, 40, 60 and 120 minutes post intervention treatment', 'description': 'If patient had to leave ward against medical advice during intervention phase - the time will be noted as well as the reason to why patient left.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Haloperidol + Promethazine + Chlorpromazine', 'description': 'Haloperidol + Promethazine + Chlorpromazine: This is the usual treatment given by this hospital during an aggressive psychiatric episode.'}, {'id': 'FG001', 'title': 'Haloperidol + Promethazine', 'description': 'Haloperidol + Promethazine: This is the second most used psycho-pharmacological combination used in this hospital during an aggressive psychiatric episode.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '48'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Haloperidol + Promethazine + Chlorpromazine', 'description': 'Haloperidol + Promethazine + Chlorpromazine: This is the usual treatment given by this hospital during an aggressive psychiatric episode.'}, {'id': 'BG001', 'title': 'Haloperidol + Promethazine', 'description': 'Haloperidol + Promethazine: This is the second most used psycho-pharmacological combination used in this hospital during an aggressive psychiatric episode.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '37', 'spread': '11.4', 'groupId': 'BG000'}, {'value': '36', 'spread': '12.3', 'groupId': 'BG001'}, {'value': '36', 'spread': '11.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Age of participant', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '5 withdrawn from follow up citing unwillingness to be involved in the trial.\n\n1 withdrawn from hospital care by relevant authorities.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-08-21', 'size': 1702926, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_003.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2022-06-12T10:36', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2019-07-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-12', 'studyFirstSubmitDate': '2018-08-15', 'resultsFirstSubmitDate': '2022-03-16', 'studyFirstSubmitQcDate': '2018-08-19', 'lastUpdatePostDateStruct': {'date': '2022-06-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-06-12', 'studyFirstPostDateStruct': {'date': '2018-08-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants According to the Time Taken for Aggressive Behaviour to Change to Calm and Tranquil', 'timeFrame': '20, 40, 60 and 120 minutes post intervention treatment', 'description': 'Patient no longer exhibiting aggressive behavior both verbal and physical post intervention treatment. A primary measure of outcome form will contain a Calm or Tranquil column followed by four rows: 20 mins, 40 mins, 60 mins and 120 mins post intervention medication. The boxes would be ticked depending if the patient meets the primary measure of outcome within the time frame provided.'}], 'secondaryOutcomes': [{'measure': 'Time Taken for Patient to Fall Asleep Post Intervention', 'timeFrame': '20, 40, 60 and 120 minutes post intervention treatment', 'description': 'Patient has fallen asleep and is no longer aggressive post intervention treatment and will be noted on the outcomes form which includes a checklist of different time intervals: 20, 40, 60 and 120 minutes post intervention treatment.'}, {'measure': 'Time Patient Was Placed in Straitjacket/Restraint Post Intervention Treatment', 'timeFrame': '20, 40, 60 and 120 minutes post intervention treatment', 'description': 'If patient was placed in a straitjacket post intervention due to aggression - this would be noted on the outcomes form which includes a checklist at certain time intervals 20,40,60 and 120 minutes post intervention treatment.'}, {'measure': 'Time Noted Where Important Adverse Effects Occurred Post Intervention', 'timeFrame': '20, 40, 60 and 120 minutes post intervention treatment', 'description': 'If patient exhibits any adverse effects post intervention treatment, this will be noted within the time frames.'}, {'measure': 'Time Patient Left the Ward Against Medical Advice During the Time Period After the Intervention Was Administered.', 'timeFrame': '20, 40, 60 and 120 minutes post intervention treatment', 'description': 'If patient had to leave ward against medical advice during intervention phase - the time will be noted as well as the reason to why patient left.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psychiatric Emergency', 'Aggression', 'Agitation']}, 'referencesModule': {'references': [{'pmid': '32528650', 'type': 'DERIVED', 'citation': 'Dib JE, Adams CE, Ikdais WH, Atallah E, Yaacoub HE, Merheb TJ, Kazour F, Tahan F, Haddad G, Zoghbi M, Azar J, Haddad C, Hallit S. 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). F1000Res. 2019 Aug 15;8:1442. doi: 10.12688/f1000research.19933.1. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomised controlled trial comparing haloperidol + promethazine versus haloperidol + promethazine + chlorpromazine for agitated patients in the emergency department.', 'detailedDescription': 'This is a randomised controlled trial comparing haloperidol + promethazine versus haloperidol + promethazine + chlorpromazine for agitated patients in the emergency department. Around 10% of patients will present to the psychiatric emergency unit with a violent episode that requires rapid tranquilisation. Surveys of practice and opinion has shown that variety of methods have been used and no universal option exists. This study will look at Haloperidol plus promethazine versus haloperidol plus promethazine plus chlorpromazine in violent aggressive psychiatric patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient will be eligible if (1) requiring emergency acute intramuscular sedation because of disturbed and dangerous behaviour and (2) if the clinician is uncertain of the benefits between haloperidol plus promethazine vs haloperidol plus promethazine plus chlorpromazine.\n* Gender - both male and female\n* Age (18-64)\n* Clinician is unaware on the effects of either treatment interventions\n\nExclusion Criteria:\n\n* If the clinician KNOWS one treatment has benefit over another for a particular person\n* If the clinician is aware of a contra-indication of one of the treatments\n* If there is an Advanced Directive expressing a wish for one or other, or another treatment in the emergency setting.\n* If the clinician does not want to undertake for both personal and professional reasons.\n* If the participant is known to be allergic to one or more of the interventions\n* Already randomized\n* Already sedated\n* Accompanying person (Friend/Family/Police Officer) refuses patient trial entry'}, 'identificationModule': {'nctId': 'NCT03639558', 'acronym': 'TREC', 'briefTitle': 'TREC-Lebanon: A Trial for Rapid Tranquilisation for Agitated Patients in the Emergency Setting', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hopital Psychiatrique De La Croix'}, 'officialTitle': 'TREC-Lebanon Trial: A Randomised Controlled Trial for Rapid Tranquilisation for Agitated Patients in the Emergency Setting', 'orgStudyIdInfo': {'id': 'DPAP - 2018 - 0138 - 1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Haloperidol + Promethazine + Chlorpromazine', 'description': 'Haloperidol + Promethazine + Chlorpromazine are all psychiatric drugs that have been well tested. The combination of these 3 drugs, however, have never been randomised.', 'interventionNames': ['Drug: Haloperidol + Promethazine + Chlorpromazine']}, {'type': 'EXPERIMENTAL', 'label': 'Haloperidol + Promethazine', 'description': 'Haloperidol + Promethazine are both psychiatric drugs with antipsychotic and calming properties.', 'interventionNames': ['Drug: Haloperidol + Promethazine']}], 'interventions': [{'name': 'Haloperidol + Promethazine + Chlorpromazine', 'type': 'DRUG', 'otherNames': ['HPC'], 'description': 'This is the usual treatment given by this hospital during an aggressive psychiatric episode.', 'armGroupLabels': ['Haloperidol + Promethazine + Chlorpromazine']}, {'name': 'Haloperidol + Promethazine', 'type': 'DRUG', 'otherNames': ['HP'], 'description': 'This is the second most used psycho-pharmacological combination used in this hospital during an aggressive psychiatric episode.', 'armGroupLabels': ['Haloperidol + Promethazine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beirut', 'state': 'Jal L Dib', 'country': 'Lebanon', 'facility': 'Hôpital Psychiatrique De La Croix', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}, {'city': 'Beirut', 'country': 'Lebanon', 'facility': 'Psychiatric Hospital of the Cross', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Joseph Dib', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'University of Nottingham', 'class': 'OTHER'}, {'name': 'Hopital Psychiatrique De La Croix', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director of Trial Research', 'investigatorFullName': 'Joseph Dib', 'investigatorAffiliation': 'Hopital Psychiatrique De La Croix'}}}}