Trial · NCT03639558
TREC-Lebanon: A Trial for Rapid Tranquilisation for Agitated Patients in the Emergency Setting
NCT03639558, Phase 4, Completed, Joseph Dib; results first posted 2022-06-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. TREC-Lebanon: A Trial for Rapid Tranquilisation for Agitated Patients in the Emergency Setting. Trials, record NCT03639558. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03639558
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- TREC-Lebanon: A Trial for Rapid Tranquilisation for Agitated Patients in the Emergency Setting
- NCT number
- NCT03639558
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 100 participants, actual
- Lead sponsor
- Joseph Dib
- Conditions
- Psychiatric Emergency, Aggression, Agitation
- Interventions
- Haloperidol + Promethazine + Chlorpromazine, Haloperidol + Promethazine
- First posted
- 2018-08-21
- Last updated
- 2022-06-14
- Results first posted
- 2022-06-14
- Limitations and caveats
Possible limitations for this trial are that there are no Emergency Departments; therefore residents must always carry the TREC envelopes at all times, increasing the risk for error (i.e. misplacing envelope, using wrong envelope, etc.). Despite the limitation, the chances of error remain low due to the small sample size of 100.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants According to the Time Taken for Aggressive Behaviour to Change to Calm and Tranquil | 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. |
| Secondary | Time Taken for Patient to Fall Asleep Post Intervention | 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. |
| Secondary | Time Patient Was Placed in Straitjacket/Restraint Post Intervention Treatment | 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. |
| Secondary | Time Noted Where Important Adverse Effects Occurred Post Intervention | 20, 40, 60 and 120 minutes post intervention treatment | If patient exhibits any adverse effects post intervention treatment, this will be noted within the time frames. |
| Secondary | Time Patient Left the Ward Against Medical Advice During the Time Period After the Intervention Was Administered. | 20, 40, 60 and 120 minutes post intervention treatment | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants According to the Time Taken for Aggressive Behaviour to Change to Calm and Tranquil | 20, 40, 60 and 120 minutes post intervention treatment | participants | NUMBER | |
| SECONDARY | Time Taken for Patient to Fall Asleep Post Intervention | 20, 40, 60 and 120 minutes post intervention treatment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time Patient Was Placed in Straitjacket/Restraint Post Intervention Treatment | 20, 40, 60 and 120 minutes post intervention treatment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time Noted Where Important Adverse Effects Occurred Post Intervention | 20, 40, 60 and 120 minutes post intervention treatment | Total number of participants who were analysed for adverse effects post intervention. No patients exhibited adverse effects in this study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time Patient Left the Ward Against Medical Advice During the Time Period After the Intervention Was Administered. | 20, 40, 60 and 120 minutes post intervention treatment | Data not collected. |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants According to the Time Taken for Aggressive Behaviour to Change to Calm and Tranquil | Haloperidol + Promethazine + Chlorpromazine | Calm or tranquil at 20 minutes | 18 | participants | |
| Number of Participants According to the Time Taken for Aggressive Behaviour to Change to Calm and Tranquil | Haloperidol + Promethazine | Calm or tranquil at 20 minutes | 14 | participants | |
| Number of Participants According to the Time Taken for Aggressive Behaviour to Change to Calm and Tranquil | Haloperidol + Promethazine + Chlorpromazine | Calm or tranquil at 40 minutes | 41 | participants | |
| Number of Participants According to the Time Taken for Aggressive Behaviour to Change to Calm and Tranquil | Haloperidol + Promethazine | Calm or tranquil at 40 minutes | 25 | participants | |
| Number of Participants According to the Time Taken for Aggressive Behaviour to Change to Calm and Tranquil | Haloperidol + Promethazine + Chlorpromazine | Calm or tranquil at 60 minutes | 45 | participants | |
| Number of Participants According to the Time Taken for Aggressive Behaviour to Change to Calm and Tranquil | Haloperidol + Promethazine | Calm or tranquil at 60 minutes | 35 | participants | |
| Number of Participants According to the Time Taken for Aggressive Behaviour to Change to Calm and Tranquil | Haloperidol + Promethazine + Chlorpromazine | Calm or tranquil at 120 minutes | 47 | participants | |
| Number of Participants According to the Time Taken for Aggressive Behaviour to Change to Calm and Tranquil | Haloperidol + Promethazine | Calm or tranquil at 120 minutes | 35 | participants | |
| Time Taken for Patient to Fall Asleep Post Intervention | Haloperidol + Promethazine + Chlorpromazine | Asleep at 20 minutes | 0 | Participants | |
| Time Taken for Patient to Fall Asleep Post Intervention | Haloperidol + Promethazine | Asleep at 20 minutes | 2 | Participants |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Haloperidol + Promethazine + Chlorpromazine | 52 | |
| Overall Study | STARTED | Haloperidol + Promethazine | 48 | |
| Overall Study | COMPLETED | Haloperidol + Promethazine + Chlorpromazine | 51 | |
| Overall Study | COMPLETED | Haloperidol + Promethazine | 43 | |
| Overall Study | NOT COMPLETED | Haloperidol + Promethazine + Chlorpromazine | 1 | |
| Overall Study | NOT COMPLETED | Haloperidol + Promethazine | 5 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Haloperidol + Promethazine + Chlorpromazine | 0 | 52 |
| Total, all-cause mortality | Haloperidol + Promethazine | 0 | 48 |
| Total, other adverse events | Haloperidol + Promethazine + Chlorpromazine | 0 | 52 |
| Total, other adverse events | Haloperidol + Promethazine | 0 | 48 |
| Total, serious adverse events | Haloperidol + Promethazine + Chlorpromazine | 0 | 52 |
| Total, serious adverse events | Haloperidol + Promethazine | 0 | 48 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32528650 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Haloperidol + Promethazine + Chlorpromazine vs Haloperidol + Promethazine: Time Noted Where Important Adverse Effects Occurred Post Intervention | Trial comparisons |
| Haloperidol + Promethazine + Chlorpromazine vs Haloperidol + Promethazine: deaths from any cause | Trial comparisons |
| Haloperidol + Promethazine + Chlorpromazine vs Haloperidol + Promethazine: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03639558
GET https://conductscience.org/api/trials/v1/NCT03639558/results?page=2