NCT03639558

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Joseph Dib · Other Government
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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.

Conditions

• Psychiatric Emergency
• Aggression
• Agitation

Interventions

Type	Name	Description
DRUG	Haloperidol + Promethazine + Chlorpromazine	This is the usual treatment given by this hospital during an aggressive psychiatric episode.
DRUG	Haloperidol + Promethazine	This is the second most used psycho-pharmacological combination used in this hospital during an aggressive psychiatric episode.

Timeline

• Start date: 2018-08-28
• Primary completion: 2019-07-01
• Completion: 2019-07-07
• First posted: 2018-08-21
• Last updated: 2022-06-14
• Results posted: 2022-06-14

Locations

2 sites across 1 country: Lebanon

Regulatory

• FDA-regulated drug study