Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Nottingham | OTHER |
| Hopital Psychiatrique De La Croix | OTHER_GOV |
Not provided
Not provided
Not provided
This is a randomised controlled trial comparing haloperidol + promethazine versus haloperidol + promethazine + chlorpromazine for agitated patients in the emergency department.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Haloperidol + Promethazine + Chlorpromazine | Active Comparator | Haloperidol + Promethazine + Chlorpromazine are all psychiatric drugs that have been well tested. The combination of these 3 drugs, however, have never been randomised. |
|
| Haloperidol + Promethazine | Experimental | Haloperidol + Promethazine are both psychiatric drugs with antipsychotic and calming properties. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Haloperidol + Promethazine + Chlorpromazine | Drug | This is the usual treatment given by this hospital during an aggressive psychiatric episode. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants According to the Time Taken for Aggressive Behaviour to Change to Calm and Tranquil | 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. | 20, 40, 60 and 120 minutes post intervention treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Time Taken for Patient to Fall Asleep Post Intervention | 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. | 20, 40, 60 and 120 minutes post intervention treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Psychiatrique De La Croix | Beirut | Jal L Dib | Lebanon | |||
| Psychiatric Hospital of the Cross |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32528650 | Derived | Dib JE, Adams CE, Ikdais WH, Atallah E, Yaacoub HE, Merheb TJ, Kazour F, Tahan F, Haddad G, Zoghbi M, Azar J, Haddad C, Hallit S. Study protocol for a randomised controlled trial of haloperidol plus promethazine plus chlorpromazine versus haloperidol plus promethazine for rapid tranquilisation for agitated psychiatric patients in the emergency setting (TREC-Lebanon). F1000Res. 2019 Aug 15;8:1442. doi: 10.12688/f1000research.19933.1. eCollection 2019. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Haloperidol + Promethazine + Chlorpromazine | Haloperidol + Promethazine + Chlorpromazine: This is the usual treatment given by this hospital during an aggressive psychiatric episode. |
| FG001 | Haloperidol + Promethazine | Haloperidol + Promethazine: This is the second most used psycho-pharmacological combination used in this hospital during an aggressive psychiatric episode. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Haloperidol + Promethazine + Chlorpromazine | Haloperidol + Promethazine + Chlorpromazine: This is the usual treatment given by this hospital during an aggressive psychiatric episode. |
| BG001 | Haloperidol + Promethazine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants According to the Time Taken for Aggressive Behaviour to Change to Calm and Tranquil | 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. | Posted | Number | participants | 20, 40, 60 and 120 minutes post intervention treatment |
|
10 months from time of intervention.
No change of definitions pertaining to adverse events. No further relevant information to be provided.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Haloperidol + Promethazine + Chlorpromazine | Haloperidol + Promethazine + Chlorpromazine: This is the usual treatment given by this hospital during an aggressive psychiatric episode. |
Not provided
Not provided
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joseph Dib | University of Nottingham/Psychiatric Hospital of the Cross | 07748668553 | joseph.elie.dib@gmail.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Aug 21, 2018 | Jun 12, 2022 | Prot_SAP_ICF_003.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000374 | Aggression |
| D011595 | Psychomotor Agitation |
| ID | Term |
|---|---|
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012919 | Social Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D006220 | Haloperidol |
| D011398 | Promethazine |
| D002746 | Chlorpromazine |
| ID | Term |
|---|---|
| D002090 | Butyrophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| D011437 | Propylamines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Haloperidol + Promethazine | Drug | 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 | 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. | 20, 40, 60 and 120 minutes post intervention treatment |
| Time Noted Where Important Adverse Effects Occurred Post Intervention | If patient exhibits any adverse effects post intervention treatment, this will be noted within the time frames. | 20, 40, 60 and 120 minutes post intervention treatment |
| Time Patient Left the Ward Against Medical Advice During the Time Period After the Intervention Was Administered. | 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. | 20, 40, 60 and 120 minutes post intervention treatment |
| Beirut |
| Lebanon |
Haloperidol + Promethazine: This is the second most used psycho-pharmacological combination used in this hospital during an aggressive psychiatric episode.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Age of participant | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | 5 withdrawn from follow up citing unwillingness to be involved in the trial. 1 withdrawn from hospital care by relevant authorities. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
Haloperidol + Promethazine: This is the second most used psycho-pharmacological combination used in this hospital during an aggressive psychiatric episode. |
|
|
| Secondary | Time Taken for Patient to Fall Asleep Post Intervention | 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. | Posted | Count of Participants | Participants | 20, 40, 60 and 120 minutes post intervention treatment |
|
|
|
| Secondary | Time Patient Was Placed in Straitjacket/Restraint 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. | Posted | Count of Participants | Participants | 20, 40, 60 and 120 minutes post intervention treatment |
|
|
|
| Secondary | Time Noted Where Important Adverse Effects Occurred Post Intervention | If patient exhibits any adverse effects post intervention treatment, this will be noted within the time frames. | Total number of participants who were analysed for adverse effects post intervention. No patients exhibited adverse effects in this study. | Posted | Count of Participants | Participants | 20, 40, 60 and 120 minutes post intervention treatment |
|
|
|
| Secondary | Time Patient Left the Ward Against Medical Advice During the Time Period After the Intervention Was Administered. | 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. | Data not collected. | Posted | 20, 40, 60 and 120 minutes post intervention treatment |
|
|
| 0 |
| 52 |
| 0 |
| 52 |
| 0 |
| 52 |
| EG001 | Haloperidol + Promethazine | Haloperidol + Promethazine: This is the second most used psycho-pharmacological combination used in this hospital during an aggressive psychiatric episode. | 0 | 48 | 0 | 48 | 0 | 48 |
Not provided
Not provided
Not provided
| D020820 |
| Dyskinesias |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011596 | Psychomotor Disorders |
| D019954 | Neurobehavioral Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000588 |
| Amines |
| D010640 | Phenothiazines |
| D013457 | Sulfur Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Asleep at 60 minutes |
|
| Asleep at 120 minutes |
|
| Restraints at 60 minutes |
|
| Restraints at 120 minutes |
|