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

NCT03639558 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: DPAP - 2018 - 0138 - 1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Psychiatric Emergency; Aggression; Agitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Time Taken for Patient to Fall Asleep Post Intervention

  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

• Time Noted Where Important Adverse Effects Occurred Post Intervention

  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.

  20, 40, 60 and 120 minutes post intervention treatment

Study Arms (2)

Haloperidol + Promethazine + Chlorpromazine

ACTIVE COMPARATOR

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

Haloperidol + Promethazine

EXPERIMENTAL

Haloperidol + Promethazine are both psychiatric drugs with antipsychotic and calming properties.

Drug: Haloperidol + Promethazine

Interventions

Haloperidol + Promethazine + Chlorpromazine DRUG

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

Also known as: HPC

Haloperidol + Promethazine + Chlorpromazine

Haloperidol + Promethazine DRUG

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

Also known as: HP

Haloperidol + Promethazine

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Joseph Dib: lead
• University of Nottingham: collaborator
• Hopital Psychiatrique De La Croix: collaborator

Study Sites (2)

Hôpital Psychiatrique De La Croix

Beirut, Jal L Dib, Lebanon

Location

Psychiatric Hospital of the Cross

Beirut, Lebanon

Location

Related Publications (1)

• 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.

  PMID: 32528650 DERIVED

MeSH Terms

Conditions

Aggression; Psychomotor Agitation

Interventions

Haloperidol; Promethazine; Chlorpromazine

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Butyrophenones; Ketones; Organic Chemicals; Propylamines; Amines; Phenothiazines; Sulfur Compounds; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Possible limitations for this trial are that there are no Emergency Departments; therefore residents must always carry the TREC envelopes at all times, increasing the risk for error (i.e. misplacing envelope, using wrong envelope, etc.). Despite the limitation, the chances of error remain low due to the small sample size of 100.

Results Point of Contact

• Title: Dr. Joseph Dib
• Organization: University of Nottingham/Psychiatric Hospital of the Cross

joseph.elie.dib@gmail.com

07748668553

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Trial Research

Study Record Dates

• First Submitted: August 15, 2018
• First Posted: August 21, 2018
• Study Start: August 28, 2018
• Primary Completion: July 1, 2019
• Study Completion: July 7, 2019
• Last Updated: June 14, 2022
• Results First Posted: June 14, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

LE (2)