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Comparison of the effect of diazepam alone and in combination with haloperidol in controlling agitation caused by stimulants

Protocol summary

Study aim
Comparison of the effect of diazepam alone and in combination with haloperidol in controlling agitation caused by stimulants
Design
The method of randomization is the use of black and white beads. In this method, the black bead will be the intervention group and the white bead will be the control group. blind on both sides
Settings and conduct
The research population is those patients referred to the emergency department of hospitals affiliated to Shahid Beheshti University of Medical Sciences, who referred to this center in 1401 for the treatment of agitation caused by stimulants, according to this, all these patients were not randomized. Asan is considered as a study group in the intervention and control group. After the desired patients (N=60) were selected, the randomization method is using black and white beads. In this method, the black bead will be the intervention group and the white bead will be the control group. In the continuation of the treatment of the patients, in the diazepam group, this drug will be used with a dose of 10 mg, and in the diazepam (10 mg) + haloperidol (5 mg) group, this drug will be used. In order to evaluate the state of restlessness and relaxation, the Richmond 3 index will be used.
Participants/Inclusion and exclusion criteria
Entry criteria: over 18 years old. Exclusion criteria: lack of consent to participate in the study, presence of risk factors for cognitive disorders such as brain and nerve disease, history of moderate to severe head trauma, history of head trauma, decreased level of consciousness, glaucoma, psychosis, moderate to severe substance dependence Other, heart diseases such as long QT 2 and observing side effects of used drugs
Intervention groups
Diazepam group, from this drug with a dose of 10 mg and diazepam group (10 mg) + haloperidol (5 mg)
Main outcome variables
agitation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210720051946N6
Registration date: 2024-01-07, 1402/10/17
Registration timing: registered_while_recruiting

Last update: 2024-01-07, 1402/10/17
Update count: 0
Registration date
2024-01-07, 1402/10/17
Registrant information
Name
Peyman Erfan Talab Evini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5102 5000
Email address
peyman1346erfan@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-14, 1402/09/23
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of diazepam alone and in combination with haloperidol in controlling agitation caused by stimulants
Public title
Effect of diazepam and haloperidol in controlling agitation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria include consent to participate in the study, diagnosis of agitation with DSM 5 1 criteria following the consumption of stimulants and age over 18 years.
Exclusion criteria:
On the other hand, another set of indicators is considered as exclusion criteria, these exclusion criteria include lack of consent to participate in the study, the presence of risk factors for cognitive disorders such as the presence of brain and nerve diseases (such as seizures, dementia, Parkinson's). ), a history of moderate to severe head trauma, a history of head trauma, decreased level of consciousness, glaucoma, psychosis, moderate to severe dependence on other substances, heart diseases such as long QT 2, and observation of the side effects of the drugs used.
Age
From 18 years old
Gender
Both
Phase
0
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
After the desired patients (N=60) were selected, the patients were randomly and double-blindly divided into intervention and control groups. The randomization method was the use of black and white beads. In this method, the black bead will be the intervention group and the white bead will be the control group. Also, in order to blind the patients, they will be blinded to the other group. In the continuation of the treatment of the patients, in the diazepam group, this drug will be used with a dose of 10 mg, and in the diazepam (10 mg) + haloperidol (5 mg) group, this drug will be used. In the following, to evaluate the level of agitation, the evaluation of the level of sedation is used and its level is determined.
Blinding (investigator's opinion)
Double blinded
Blinding description
After the desired patients (N=60) were selected, the patients were randomly and double-blindly divided into intervention and control groups. The randomization method was the use of black and white beads. In this method, the black bead will be the intervention group and the white bead will be the control group. Also, in order to blind the patients, they will be blinded to the other group. In the continuation of the treatment of the patients, in the diazepam group, this drug will be used with a dose of 10 mg, and in the diazepam (10 mg) + haloperidol (5 mg) group, this drug will be used. In the following, to evaluate the level of agitation, the evaluation of the level of sedation is used and its level is determined.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committe of Shahid Beheshti University of Medical Sciences
Street address
Velenjak Square, Daneshju Blv
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2023-11-19, 1402/08/28
Ethics committee reference number
IR.SBMU.RETECH.REC.1402.451

Health conditions studied

1

Description of health condition studied
poisoned patients
ICD-10 code
F00-F99
ICD-10 code description
F00-F99

Primary outcomes

1

Description
agitation
Timepoint
0,10,15,30 min
Method of measurement
richmond questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Diazepam (10 mg) + Haloperidol (5 mg)
Category
Treatment - Drugs

2

Description
Control group: Diazepam (10 mg)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Loghman Hospital
Full name of responsible person
Peyman Erfan Talab Evini
Street address
Kamali Street
City
Tehran
Province
Tehran
Postal code
1333631151
Phone
+98 21 5541 9005
Email
peyman1346erfan@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Peyman Erfan Talab Evini
Street address
Velenjak Square
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
peyman1346erfan@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Peyman Erfan Talab Evini
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Toxicology
Street address
Kamali Street
City
Tehran
Province
Tehran
Postal code
1333631151
Phone
+98 21 5102 5000
Email
peyman1346erfan@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Peyman Erfan Talab Evini
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Toxicology
Street address
Kamali Street
City
Tehran
Province
Tehran
Postal code
1333631151
Phone
+98 21 5541 9005
Email
peyman1346erfan@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Peyman Erfan Talab Evini
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Toxicology
Street address
Kamali Street
City
Tehran
Province
Tehran
Postal code
1333631151
Phone
+98 21 5541 9005
Email
peyman1346erfan@sbmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The access period starts from the year 2024
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
People who are also engaged in pharmaceuticals and research
From where data/document is obtainable
Peyman Erfan Talab Evini
What processes are involved for a request to access data/document
Administrative correspondence seven to ten working days
Comments
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