Phase 4
Completed N=100
TREC-Lebanon: A Trial for Rapid Tranquilisation for Agitated Patients in the Emergency Setting
Psychiatric Emergency · Aggression · Agitation
Source: ClinicalTrials.gov NCT03639558 ↗
Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcomePrimary: Number of Participants According to the Time Taken for Aggressive Behaviour to Change to Calm and Tranquil — 18; 14; 41; 25 participants
◆ Published Evidence
Emerging
2citations · ~0 / year
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).
Summary
This is a randomised controlled trial comparing haloperidol + promethazine versus haloperidol + promethazine + chlorpromazine for agitated patients in the emergency department.
Linked Publications
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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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants According to the Time Taken for Aggressive Behaviour to Change to Calm and Tranquil |
18; 14; 41; 25; 45; 35 | — |
| SECONDARY Time Taken for Patient to Fall Asleep Post Intervention |
0; 2; 9; 9; 25; 10 | — |
| SECONDARY Time Patient Was Placed in Straitjacket/Restraint Post Intervention Treatment |
17; 16; 10; 13; 8; 9 | — |
| SECONDARY Time Noted Where Important Adverse Effects Occurred Post Intervention |
0; 0 | — |
| SECONDARY Time Patient Left the Ward Against Medical Advice During the Time Period After the Intervention Was Administered. |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT03639558) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.