Trial Outcomes & Findings for TREC-Lebanon: A Trial for Rapid Tranquilisation for Agitated Patients in the Emergency Setting (NCT NCT03639558)

NCT ID: NCT03639558

Last Updated: 2022-06-14

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

100 participants

Primary outcome timeframe

20, 40, 60 and 120 minutes post intervention treatment

Results posted on

2022-06-14

Participant Flow

Participant milestones

Participant milestones
Measure	Haloperidol + Promethazine + Chlorpromazine Haloperidol + Promethazine + Chlorpromazine: This is the usual treatment given by this hospital during an aggressive psychiatric episode.	Haloperidol + Promethazine Haloperidol + Promethazine: This is the second most used psycho-pharmacological combination used in this hospital during an aggressive psychiatric episode.
Overall Study STARTED	52	48
Overall Study COMPLETED	51	43
Overall Study NOT COMPLETED	1	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

5 withdrawn from follow up citing unwillingness to be involved in the trial. 1 withdrawn from hospital care by relevant authorities.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Haloperidol + Promethazine + Chlorpromazine n=52 Participants Haloperidol + Promethazine + Chlorpromazine: This is the usual treatment given by this hospital during an aggressive psychiatric episode.	Haloperidol + Promethazine n=48 Participants Haloperidol + Promethazine: This is the second most used psycho-pharmacological combination used in this hospital during an aggressive psychiatric episode.	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=52 Participants	0 Participants n=48 Participants	0 Participants n=100 Participants
Age, Categorical Between 18 and 65 years	52 Participants n=52 Participants	48 Participants n=48 Participants	100 Participants n=100 Participants
Age, Categorical >=65 years	0 Participants n=52 Participants	0 Participants n=48 Participants	0 Participants n=100 Participants
Age, Continuous	37 Years STANDARD_DEVIATION 11.4 • n=52 Participants	36 Years STANDARD_DEVIATION 12.3 • n=48 Participants	36 Years STANDARD_DEVIATION 11.8 • n=100 Participants
Sex: Female, Male Female	27 Participants n=51 Participants • 5 withdrawn from follow up citing unwillingness to be involved in the trial. 1 withdrawn from hospital care by relevant authorities.	22 Participants n=43 Participants • 5 withdrawn from follow up citing unwillingness to be involved in the trial. 1 withdrawn from hospital care by relevant authorities.	49 Participants n=94 Participants • 5 withdrawn from follow up citing unwillingness to be involved in the trial. 1 withdrawn from hospital care by relevant authorities.
Sex: Female, Male Male	24 Participants n=51 Participants • 5 withdrawn from follow up citing unwillingness to be involved in the trial. 1 withdrawn from hospital care by relevant authorities.	21 Participants n=43 Participants • 5 withdrawn from follow up citing unwillingness to be involved in the trial. 1 withdrawn from hospital care by relevant authorities.	45 Participants n=94 Participants • 5 withdrawn from follow up citing unwillingness to be involved in the trial. 1 withdrawn from hospital care by relevant authorities.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=52 Participants	0 Participants n=48 Participants	0 Participants n=100 Participants
Race (NIH/OMB) Asian	0 Participants n=52 Participants	0 Participants n=48 Participants	0 Participants n=100 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=52 Participants	0 Participants n=48 Participants	0 Participants n=100 Participants
Race (NIH/OMB) Black or African American	0 Participants n=52 Participants	0 Participants n=48 Participants	0 Participants n=100 Participants
Race (NIH/OMB) White	0 Participants n=52 Participants	0 Participants n=48 Participants	0 Participants n=100 Participants
Race (NIH/OMB) More than one race	0 Participants n=52 Participants	0 Participants n=48 Participants	0 Participants n=100 Participants
Race (NIH/OMB) Unknown or Not Reported	52 Participants n=52 Participants	48 Participants n=48 Participants	100 Participants n=100 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Haloperidol + Promethazine + Chlorpromazine n=52 Participants Haloperidol + Promethazine + Chlorpromazine: This is the usual treatment given by this hospital during an aggressive psychiatric episode.	Haloperidol + Promethazine n=48 Participants Haloperidol + Promethazine: This is the second most used psycho-pharmacological combination used in this hospital during an aggressive psychiatric episode.
Number of Participants According to the Time Taken for Aggressive Behaviour to Change to Calm and Tranquil Calm or tranquil at 20 minutes	18 participants	14 participants
Number of Participants According to the Time Taken for Aggressive Behaviour to Change to Calm and Tranquil Calm or tranquil at 40 minutes	41 participants	25 participants
Number of Participants According to the Time Taken for Aggressive Behaviour to Change to Calm and Tranquil Calm or tranquil at 60 minutes	45 participants	35 participants
Number of Participants According to the Time Taken for Aggressive Behaviour to Change to Calm and Tranquil Calm or tranquil at 120 minutes	47 participants	35 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Haloperidol + Promethazine + Chlorpromazine n=52 Participants Haloperidol + Promethazine + Chlorpromazine: This is the usual treatment given by this hospital during an aggressive psychiatric episode.	Haloperidol + Promethazine n=48 Participants Haloperidol + Promethazine: This is the second most used psycho-pharmacological combination used in this hospital during an aggressive psychiatric episode.
Time Taken for Patient to Fall Asleep Post Intervention Asleep at 120 minutes	24 Participants	18 Participants
Time Taken for Patient to Fall Asleep Post Intervention Asleep at 20 minutes	0 Participants	2 Participants
Time Taken for Patient to Fall Asleep Post Intervention Asleep at 40 minutes	9 Participants	9 Participants
Time Taken for Patient to Fall Asleep Post Intervention Asleep at 60 minutes	25 Participants	10 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Haloperidol + Promethazine + Chlorpromazine n=52 Participants Haloperidol + Promethazine + Chlorpromazine: This is the usual treatment given by this hospital during an aggressive psychiatric episode.	Haloperidol + Promethazine n=48 Participants Haloperidol + Promethazine: This is the second most used psycho-pharmacological combination used in this hospital during an aggressive psychiatric episode.
Time Patient Was Placed in Straitjacket/Restraint Post Intervention Treatment Restraints at 20 minutes	17 Participants	16 Participants
Time Patient Was Placed in Straitjacket/Restraint Post Intervention Treatment Restraints at 40 minutes	10 Participants	13 Participants
Time Patient Was Placed in Straitjacket/Restraint Post Intervention Treatment Restraints at 60 minutes	8 Participants	9 Participants
Time Patient Was Placed in Straitjacket/Restraint Post Intervention Treatment Restraints at 120 minutes	6 Participants	5 Participants

SECONDARY outcome

Timeframe: 20, 40, 60 and 120 minutes post intervention treatment

Population: Total number of participants who were analysed for adverse effects post intervention. No patients exhibited adverse effects in this study.

If patient exhibits any adverse effects post intervention treatment, this will be noted within the time frames.

Outcome measures

Outcome measures
Measure	Haloperidol + Promethazine + Chlorpromazine n=52 Participants Haloperidol + Promethazine + Chlorpromazine: This is the usual treatment given by this hospital during an aggressive psychiatric episode.	Haloperidol + Promethazine n=48 Participants Haloperidol + Promethazine: This is the second most used psycho-pharmacological combination used in this hospital during an aggressive psychiatric episode.
Time Noted Where Important Adverse Effects Occurred Post Intervention	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 20, 40, 60 and 120 minutes post intervention treatment

Population: Data not collected.

If patient had to leave ward against medical advice during intervention phase - the time will be noted as well as the reason to why patient left.

Outcome measures

Outcome data not reported

Adverse Events

Haloperidol + Promethazine + Chlorpromazine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Haloperidol + Promethazine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Joseph Dib

University of Nottingham/Psychiatric Hospital of the Cross

Phone: 07748668553

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place