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

Aggression Clinical Trial

— TREC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03639558
• Other study ID #: DPAP - 2018 - 0138 - 1
• Status: Completed
• Phase: Phase 4
• Start date: August 28, 2018
• Est. completion date: July 7, 2019

Study information

• Verified date: June 2022
• Source: Hopital Psychiatrique De La Croix
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 7, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Aggression
• Agitation
• Emergencies
• Psychiatric Emergency

Intervention

Drug:
• Haloperidol + Promethazine + Chlorpromazine
This is the usual treatment given by this hospital during an aggressive psychiatric episode.
• Haloperidol + Promethazine
This is the second most used psycho-pharmacological combination used in this hospital during an aggressive psychiatric episode.

Locations

Country	Name	City	State
Lebanon	Hôpital Psychiatrique De La Croix	Beirut	Jal L Dib
Lebanon	Psychiatric Hospital of the Cross	Beirut

Sponsors (3)

Lead Sponsor	Collaborator
Joseph Dib	Hopital Psychiatrique De La Croix, University of Nottingham

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	20, 40, 60 and 120 minutes post intervention treatment
Secondary	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
Secondary	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
Secondary	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
Secondary	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