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

Joseph Dib100 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Psychiatric Emergency Aggression Agitation

Interventions

Haloperidol + Promethazine + ChlorpromazineDRUG

This is the usual treatment given by this hospital during an aggressive psychiatric episode.

Haloperidol + PromethazineDRUG

This is the second most used psycho-pharmacological combination used in this hospital during an aggressive psychiatric episode.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Hôpital Psychiatrique De La Croix

Beirut, Jal L Dib, Lebanon

Psychiatric Hospital of the Cross

Beirut, Lebanon

Outcomes

Primary Outcomes

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.

Time frame: 20, 40, 60 and 120 minutes post intervention treatment

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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