TREC-Lebanon: A Trial for Rapid Tranquilisation for Agitated Patients in the Emergency Setting

Study Overview
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Brief Summary
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This is a randomised controlled trial comparing haloperidol + promethazine versus haloperidol + promethazine + chlorpromazine for agitated patients in the emergency department.

Detailed Description
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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.

Official Title
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TREC-Lebanon Trial: A Randomised Controlled Trial for Rapid Tranquilisation for Agitated Patients in the Emergency Setting

Conditions
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Psychiatric Emergency, Aggression, Agitation

Intervention / Treatment
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* Drug: Haloperidol + Promethazine + Chlorpromazine
* Drug: Haloperidol + Promethazine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Gender - both male and female Age (18-64) Clinician is unaware on the effects of either treatment interventions Exclusion Criteria: If the clinician KNOWS one treatment has benefit over another for a particular person If the clinician is aware of a contra-indication of one of the treatments If there is an Advanced Directive expressing a wish for one or other, or another treatment in the emergency setting. If the clinician does not want to undertake for both personal and professional reasons. If the participant is known to be allergic to one or more of the interventions Already randomized Already sedated Accompanying person (Friend/Family/Police Officer) refuses patient trial entry

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Haloperidol + Promethazine + Chlorpromazine<br>Haloperidol + Promethazine + Chlorpromazine are all psychiatric drugs that have been well tested. The combination of these 3 drugs, however, have never been randomised. | Drug: Haloperidol + Promethazine + Chlorpromazine<br>* This is the usual treatment given by this hospital during an aggressive psychiatric episode.<br>* Other names: HPC;|
| Experimental: Haloperidol + Promethazine<br>Haloperidol + Promethazine are both psychiatric drugs with antipsychotic and calming properties. | Drug: Haloperidol + Promethazine<br>* This is the second most used psycho-pharmacological combination used in this hospital during an aggressive psychiatric episode.<br>* Other names: HP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants According to the Time Taken for Aggressive Behaviour to Change to Calm and Tranquil | 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. | 20, 40, 60 and 120 minutes post intervention treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time Taken for Patient to Fall Asleep Post Intervention | 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. | 20, 40, 60 and 120 minutes post intervention treatment | 
| Time Patient Was Placed in Straitjacket/Restraint Post Intervention Treatment | 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. | 20, 40, 60 and 120 minutes post intervention treatment | 
| Time Noted Where Important Adverse Effects Occurred Post Intervention | If patient exhibits any adverse effects post intervention treatment, this will be noted within the time frames. | 20, 40, 60 and 120 minutes post intervention treatment | 
| Time Patient Left the Ward Against Medical Advice During the Time Period After the Intervention Was Administered. | 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. | 20, 40, 60 and 120 minutes post intervention treatment |