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

Joseph Dib

Status and phase: Completed; Phase 4

Conditions: Agitation; Aggression; Psychiatric Emergency

Treatments: Drug: Haloperidol + Promethazine; Drug: Haloperidol + Promethazine + Chlorpromazine

Study type: Interventional

Funder types: Other

Identifiers

NCT03639558

DPAP - 2018 - 0138 - 1

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Haloperidol + Promethazine + Chlorpromazine

Active Comparator group

Description:

Haloperidol + Promethazine + Chlorpromazine are all psychiatric drugs that have been well tested. The combination of these 3 drugs, however, have never been randomised.

Treatment:

Drug: Haloperidol + Promethazine + Chlorpromazine

Haloperidol + Promethazine

Experimental group

Description:

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

Treatment:

Drug: Haloperidol + Promethazine