CompletedPhase 4

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

Lebanon100 participantsStarted 2018-08-28

Plain-language summary

This is a randomised controlled trial comparing haloperidol + promethazine versus haloperidol + promethazine + chlorpromazine for agitated patients in the emergency department.

Who can participate

Age range

18 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT03639558

SponsorJoseph Dib

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2019-07-01

Results submitted2022-03-16

View on ClinicalTrials.gov More Psychiatric Emergency trials

Who can participate

Age range

18 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.