Phase 4
N=100
TREC-Lebanon: A Trial for Rapid Tranquilisation for Agitated Patients in the Emergency Setting
Psychiatric Emergency · Aggression · Agitation
Bottom Line
View on ClinicalTrials.gov: NCT03639558 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcome: Primary: Number of Participants According to the Time Taken for Aggressive Behaviour to Change to Calm and Tranquil — 18; 14; 41; 25 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Haloperidol + Promethazine + Chlorpromazine (Drug); Haloperidol + Promethazine (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Joseph Dib
- Primary completion
- Jul 2019
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. |
— | — |
Summary
This is a randomised controlled trial comparing haloperidol + promethazine versus haloperidol + promethazine + chlorpromazine for agitated patients in the emergency department.
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). 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.