Clinical trial NCT03639558: TREC-Lebanon: A Trial for Rapid Tranquilisation for Agitated Patients in the Emergency Setting
Official title: TREC-Lebanon Trial: A Randomised Controlled Trial for Rapid Tranquilisation for Agitated Patients in the Emergency Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psychiatric Emergency
Aggression
Agitation
Lead sponsor: Hopital Psychiatrique De La Croix
Sponsor class: OTHER_GOV
Collaborators: name: University of Nottingham
name: Hopital Psychiatrique De La Croix
First posted: 2018-08-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants According to the Time Taken for Aggressive Behaviour to Change to Calm and Tranquil
timeFrame: 20, 40, 60 and 120 minutes post intervention treatment
Secondary outcomes:
measure: Time Taken for Patient to Fall Asleep Post Intervention
timeFrame: 20, 40, 60 and 120 minutes post intervention treatment
measure: Time Patient Was Placed in Straitjacket/Restraint Post Intervention Treatment
timeFrame: 20, 40, 60 and 120 minutes post intervention treatment
measure: Time Noted Where Important Adverse Effects Occurred Post Intervention
timeFrame: 20, 40, 60 and 120 minutes post intervention treatment
measure: Time Patient Left the Ward Against Medical Advice During the Time Period After the Intervention Was Administered.
timeFrame: 20, 40, 60 and 120 minutes post intervention treatment
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Hôpital Psychiatrique De La Croix
state: Jal L Dib
city: Beirut
country: Lebanon
facility: Psychiatric Hospital of the Cross
Study officials:
References:
citation: 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.