TREC-Lebanon: A Trial for Rapid Tranquilisation for Agitated Patients in the Emergency Setting (TREC)
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|ClinicalTrials.gov Identifier: NCT03639558|
Recruitment Status : Completed
First Posted : August 21, 2018
Last Update Posted : July 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Psychiatric Emergency Aggression Agitation||Drug: Haloperidol + Promethazine + Chlorpromazine Drug: Haloperidol + Promethazine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||TREC-Lebanon Trial: A Randomised Controlled Trial for Rapid Tranquilisation for Agitated Patients in the Emergency Setting|
|Actual Study Start Date :||August 28, 2018|
|Actual Primary Completion Date :||July 1, 2019|
|Actual Study Completion Date :||July 7, 2019|
|Active Comparator: Haloperidol + Promethazine + Chlorpromazine||
Drug: Haloperidol + Promethazine + Chlorpromazine
This is the usual treatment given by this hospital during an aggressive psychiatric episode.
|Experimental: Haloperidol + Promethazine||
Drug: Haloperidol + Promethazine
This is the second most used psycho-pharmacological combination used in this hospital during an aggressive psychiatric episode.
- Assessing change of patient's aggressive behavior to calm and tranquil. [ Time Frame: 20, 40, 60 and 120 minutes post intervention treatment ]Patient no longer exhibiting aggressive behavior both verbal and physical post intervention treatment. A primary measure of outcome form will contain a Calm or Tranquil column followed by four rows: 20 mins, 40 mins, 60 mins and 120 mins post intervention medication. The boxes would be ticked depending if the patient meets the primary measure of outcome within the time frame provided.
- Time taken for patient to fall Asleep [ Time Frame: 20, 40, 60 and 120 minutes post intervention treatment ]Patient has fallen asleep and is no longer aggressive post intervention treatment and will be noted on the outcomes form which includes a checklist of different time intervals: 20, 40, 60 and 120 minutes post intervention treatment.
- Time patient was placed in Straitjacket/Restraint post intervention treatment [ Time Frame: 20, 40, 60 and 120 minutes post intervention treatment ]If patient was placed in a straitjacket post intervention due to aggression - this would be noted on the outcomes form which includes a checklist at certain time intervals 20,40,60 and 120 minutes post intervention treatment.
- Time noted where Important Adverse Effects occurred post intervention [ Time Frame: 20, 40, 60 and 120 minutes post intervention treatment ]If patient exhibits any adverse effects post intervention treatment, it would be noted on the outcomes form either at 20,40, 60 or 120 minutes post intervention.
- Time patient left the ward against medical advice during the time period after the intervention was administered. [ Time Frame: 20, 40, 60 and 120 minutes post intervention treatment ]If patient had to leave ward against medical advice during intervention phase
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03639558
|Hôpital Psychiatrique De La Croix|
|Beirut, Jal L Dib, Lebanon|
|Psychiatric Hospital of the Cross|