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

NCT ID: NCT03639558

Last Updated: 2022-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-28
• Study Completion Date: 2019-07-07

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.

Conditions

Psychiatric Emergency; Aggression; Agitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Haloperidol + Promethazine + Chlorpromazine

Intervention Type: DRUG

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

Haloperidol + Promethazine

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

Group Type: EXPERIMENTAL

Haloperidol + Promethazine

Intervention Type: DRUG

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

Interventions

Haloperidol + Promethazine + Chlorpromazine

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

Intervention Type: DRUG

Haloperidol + Promethazine

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

Intervention Type: DRUG

Other Intervention Names

HPC; HP

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Nottingham

OTHER

Sponsor Role: collaborator

Hopital Psychiatrique De La Croix

OTHER_GOV

Sponsor Role: collaborator

Joseph Dib

OTHER_GOV

Sponsor Role: lead

Responsible Party

Joseph Dib

Director of Trial Research

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Hôpital Psychiatrique De La Croix

Beirut, Jal L Dib, Lebanon

Psychiatric Hospital of the Cross

Beirut, , Lebanon

Countries

Lebanon

References

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.

Reference Type: DERIVED

PMID: 32528650 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

DPAP - 2018 - 0138 - 1

Identifier Type: -

Identifier Source: org_study_id