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Completed

NCT Number: NCT03639558

TREC-Lebanon: A 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.

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Key information

Conditions

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

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hôpital Psychiatrique De La Croix, Beirut, Jal L Dib, Lebanon

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Haloperidol + Promethazine + Chlorpromazine

Drug

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

Other names: HPC

Haloperidol + Promethazine

Drug

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

Other names: HP

Primary outcomes

  1. Number of Participants According to the Time Taken for Aggressive Behaviour to Change to Calm and Tranquil

    Time frame: 20, 40, 60 and 120 minutes post intervention treatment

    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.

Secondary outcomes

  1. Time Taken for Patient to Fall Asleep Post Intervention

    Time frame: 20, 40, 60 and 120 minutes post intervention treatment

    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.

  2. Time Patient Was Placed in Straitjacket/Restraint Post Intervention Treatment

    Time frame: 20, 40, 60 and 120 minutes 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.

  3. Time Noted Where Important Adverse Effects Occurred Post Intervention

    Time frame: 20, 40, 60 and 120 minutes post intervention treatment

    If patient exhibits any adverse effects post intervention treatment, this will be noted within the time frames.

  4. Time Patient Left the Ward Against Medical Advice During the Time Period After the Intervention Was Administered.

    Time frame: 20, 40, 60 and 120 minutes post intervention treatment

    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.

Sponsors and collaborators

Lead sponsor

Joseph Dib

Other Gov

Collaborators

  • Hopital Psychiatrique De La Croix
  • University of Nottingham

Registry information

Official study title

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

Acronym: TREC

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 21, 2018
Registry last updated
Jun 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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