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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03639558

Acronym

TREC

Enrollment

100

Registered

2018-08-21

Start date

2018-08-28

Completion date

2019-07-07

Last updated

2022-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aggression, Agitation, Psychiatric Emergency

Brief summary

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

Detailed description

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.

Interventions

DRUGHaloperidol + Promethazine + Chlorpromazine

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

DRUGHaloperidol + Promethazine

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

Lebanon

Participant flow

Participants by arm

Arm	Count
Haloperidol + Promethazine + Chlorpromazine Haloperidol + Promethazine + Chlorpromazine: This is the usual treatment given by this hospital during an aggressive psychiatric episode.	52
Haloperidol + Promethazine Haloperidol + Promethazine: This is the second most used psycho-pharmacological combination used in this hospital during an aggressive psychiatric episode.	48
Total	100

Baseline characteristics

Characteristic	Haloperidol + Promethazine + Chlorpromazine	Haloperidol + Promethazine	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	52 Participants	48 Participants	100 Participants
Age, Continuous	37 Years STANDARD_DEVIATION 11.4	36 Years STANDARD_DEVIATION 12.3	36 Years STANDARD_DEVIATION 11.8
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	52 Participants	48 Participants	100 Participants
Race (NIH/OMB) White	0 Participants	0 Participants	0 Participants
Sex: Female, Male Female	27 Participants	22 Participants	49 Participants
Sex: Female, Male Male	24 Participants	21 Participants	45 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 52	0 / 48
other Total, other adverse events	0 / 52	0 / 48
serious Total, serious adverse events	0 / 52	0 / 48

Outcome results

Primary

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.