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

• Status: Completed
• Trial end date: 2019-07-07
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Joseph Dib
• Collaborators: Hopital Psychiatrique De La Croix; University of Nottingham
• Treatments: Chlorpromazine; Diphenhydramine; Haloperidol; Haloperidol decanoate; Promethazine

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