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

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

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

Study Overview

• Status: Completed
• Conditions: Aggression; Agitation; Psychiatric Emergency
• Intervention / Treatment: Drug: Haloperidol + Promethazine + Chlorpromazine; Drug: Haloperidol + Promethazine

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon
    • Psychiatric Hospital of the Cross
  • Jal L Dib
    • Beirut, Jal L Dib, Lebanon
      • Hôpital Psychiatrique De La Croix

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 62 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Haloperidol + Promethazine + Chlorpromazine; 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; This is the usual treatment given by this hospital during an aggressive psychiatric episode.; Other Names: HPC
Experimental: Haloperidol + Promethazine; Haloperidol + Promethazine are both psychiatric drugs with antipsychotic and calming properties.	Drug: Haloperidol + Promethazine; This is the second most used psycho-pharmacological combination used in this hospital during an aggressive psychiatric episode.; Other Names: HP

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Joseph Dib
• Collaborators: University of Nottingham; Hopital Psychiatrique De La Croix

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2018
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): July 7, 2019

Study Registration Dates

• First Submitted: August 15, 2018
• First Submitted That Met QC Criteria: August 19, 2018
• First Posted (Actual): August 21, 2018

Study Record Updates

• Last Update Posted (Actual): June 14, 2022
• Last Update Submitted That Met QC Criteria: June 12, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Pathologic Processes; Disease Attributes; Aggression; Emergencies; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Dopamine Agents; Dopamine Antagonists; Hypnotics and Sedatives; Anesthetics, Local; Anti-Allergic Agents; Sleep Aids, Pharmaceutical; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Anti-Dyskinesia Agents; Diphenhydramine; Promethazine; Haloperidol; Haloperidol decanoate; Chlorpromazine
• Other Study ID Numbers: DPAP - 2018 - 0138 - 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes