Back to resultsTREC-Lebanon: A Trial for Rapid Tranquilisation for Agitated Patients in the Emergency Setting (TREC)
Primary Purpose
Psychiatric Emergency, Aggression, Agitation
Status
Completed
Phase
Phase 4
Locations
Lebanon
Study Type
Interventional
Intervention
Haloperidol + Promethazine + Chlorpromazine
Haloperidol + Promethazine
Sponsored by
About this trial
This is an interventional treatment trial for Psychiatric Emergency
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
Sites / Locations
- Hôpital Psychiatrique De La Croix
- Psychiatric Hospital of the Cross
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Haloperidol + Promethazine + Chlorpromazine
Haloperidol + Promethazine
Arm Description
Haloperidol + Promethazine + Chlorpromazine are all psychiatric drugs that have been well tested. The combination of these 3 drugs, however, have never been randomised.
Haloperidol + Promethazine are both psychiatric drugs with antipsychotic and calming properties.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Time Taken for Patient to Fall Asleep Post Intervention
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.
Time Patient Was Placed in Straitjacket/Restraint 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.
Time Noted Where Important Adverse Effects Occurred Post Intervention
If patient exhibits any adverse effects post intervention treatment, this will be noted within the time frames.
Time Patient Left the Ward Against Medical Advice During the Time Period After the Intervention Was Administered.
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.
Full Information
NCT ID
NCT03639558
First Posted
August 15, 2018
Last Updated
June 12, 2022
Sponsor
Joseph Dib
Collaborators
University of Nottingham, Hopital Psychiatrique De La Croix
1. Study Identification
Unique Protocol Identification Number
NCT03639558
Brief Title
TREC-Lebanon: A Trial for Rapid Tranquilisation for Agitated Patients in the Emergency Setting
Acronym
TREC
Official Title
TREC-Lebanon Trial: A Randomised Controlled Trial for Rapid Tranquilisation for Agitated Patients in the Emergency Setting
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
August 28, 2018 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
July 7, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Joseph Dib
Collaborators
University of Nottingham, Hopital Psychiatrique De La Croix
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychiatric Emergency, Aggression, Agitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Haloperidol + Promethazine + Chlorpromazine
Arm Type
Active Comparator
Arm Description
Haloperidol + Promethazine + Chlorpromazine are all psychiatric drugs that have been well tested. The combination of these 3 drugs, however, have never been randomised.
Arm Title
Haloperidol + Promethazine
Arm Type
Experimental
Arm Description
Haloperidol + Promethazine are both psychiatric drugs with antipsychotic and calming properties.
Intervention Type
Drug
Intervention Name(s)
Haloperidol + Promethazine + Chlorpromazine
Other Intervention Name(s)
HPC
Intervention Description
This is the usual treatment given by this hospital during an aggressive psychiatric episode.
Intervention Type
Drug
Intervention Name(s)
Haloperidol + Promethazine
Other Intervention Name(s)
HP
Intervention Description
This is the second most used psycho-pharmacological combination used in this hospital during an aggressive psychiatric episode.
Primary Outcome Measure Information:
Title
Number of Participants According to the Time Taken for Aggressive Behaviour to Change to Calm and Tranquil
Description
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.
Time Frame
20, 40, 60 and 120 minutes post intervention treatment
Secondary Outcome Measure Information:
Title
Time Taken for Patient to Fall Asleep Post Intervention
Description
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.
Time Frame
20, 40, 60 and 120 minutes post intervention treatment
Title
Time Patient Was Placed in Straitjacket/Restraint Post Intervention Treatment
Description
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.
Time Frame
20, 40, 60 and 120 minutes post intervention treatment
Title
Time Noted Where Important Adverse Effects Occurred Post Intervention
Description
If patient exhibits any adverse effects post intervention treatment, this will be noted within the time frames.
Time Frame
20, 40, 60 and 120 minutes post intervention treatment
Title
Time Patient Left the Ward Against Medical Advice During the Time Period After the Intervention Was Administered.
Description
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.
Time Frame
20, 40, 60 and 120 minutes post intervention treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Hôpital Psychiatrique De La Croix
City
Beirut
State/Province
Jal L Dib
Country
Lebanon
Facility Name
Psychiatric Hospital of the Cross
City
Beirut
Country
Lebanon
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32528650
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.
Results Reference
derived
Learn more about this trial
TREC-Lebanon: A Trial for Rapid Tranquilisation for Agitated Patients in the Emergency Setting
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