The effects of propranolol on clinical outcomes in patients with post-traumatic stress and burns
Design
Clinical trial with control and intervention group, specific randomized, phase 3 on 52 patients. Blocking was used for randomization
Settings and conduct
After receiving an official letter from the University of Medical Sciences and Informed consent in writing of each patient sample available in 24 hours by a doctor burn experienced penetrated check routine based on the inclusion criteria for the study are .During 48 hours of hospitalization, after stabilizing the hemodynamic status and fluid therapy, they are treated in the intervention group and the control group by randomly assigned random sampling using block blocking.
Participants/Inclusion and exclusion criteria
Inclusion criteria have wounds that 20 to 50% of the total body surface area TBSA and second and third degree , need treatment with at least one skin graft surgery, 48 hours after hospitalization in the intervention group to receive propranolol for at least 4 consecutive days, satisfaction with participating in data collection
Intervention groups
In the control group, patients are treated with standard burn care. Propranolol administration by specialist burns unit and after consultation with the doctor's advice heart for oral or nasal cannula with the same dose of 10 mg twice daily at 6 am and evening with monitoring vital signs routinely match. Daily monitoring of hemodynamic status (heart rate and blood pressure of the left hand using non-invasive cuff measurement) is performed before drug administration in the intervention group and after drug administration routinely in both groups in the wards.
Main outcome variables
Post-traumatic stress, Hemoglobin and hematocrit, Successful skin grafting, Average length of hospital stay
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190919044819N2
Registration date:2020-09-13, 1399/06/23
Registration timing:registered_while_recruiting
Last update:2020-09-13, 1399/06/23
Update count:0
Registration date
2020-09-13, 1399/06/23
Registrant information
Name
narges hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7768 4704
Email address
nargeshossini123@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-15, 1399/05/25
Expected recruitment end date
2021-04-15, 1400/01/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of propranolol on post-traumatic stress and clinical outcomes in burn patients
Public title
The effect of propranolol on post-traumatic stress and clinical outcomes in burn patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Able to talking
Wounds that are 20 to 50 percent of the total body surface area of TBSA And have wounds that are second and third degree
Requires treatment with at least one skin graft surgery
Receive propranolol for at least 4 consecutive days 48 hours after hospitalization in the intervention group
Satisfaction with participating in data collection
Exclusion criteria:
Medical conditions Contraindications to propranolol (beta-blocker contraindication)
pregnancy
bipolar disorder, head injury
cardiopulmonary disease, endocrine and peripheral, asthma, systolic blood pressure less than 90, heart rate 60, inhalation damage
5 years of malignancy, history of AIDS, diabetes
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
patients are treated with standard burn care.Allocated random sampling using block classification in two groups of 52 blocks including 26 participants in the intervention group and 26 participants in the group will be witnessed.
In the intervention group treated with propranolol to patients treated with standard of care of the burn begins.
In the control group, patients are treated with standard burn care.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Street address
Shahid Bahonar Boulevard, Qazvin University of Medical Sciences
City
gazvin
Province
Qazvin
Postal code
34417431874
Approval date
2020-07-26, 1399/05/05
Ethics committee reference number
IR.QUMS.REC.1399.195
Health conditions studied
1
Description of health condition studied
burn
ICD-10 code
T21.21XD
ICD-10 code description
Burn of second degree of chest wall, subsequent encounter
Primary outcomes
1
Description
post-traumatic stress
Timepoint
At the beginning of the study (before the intervention) and And one month after the intervention
Method of measurement
Impact of Event Scale-Revised
Secondary outcomes
1
Description
Successful skin grafting
Timepoint
Both groups will be evaluated within two weeks and four weeks after discharge
Method of measurement
Clinical examination in which the evaluation of the success of the transplant means a transplant that is pink in color and firmly attached to the base of the transplant area.
2
Description
Duration of hospitalization
Timepoint
The first and last day of hospitalization in the ward
Method of measurement
Counting by number of days
Intervention groups
1
Description
Intervention group: The intervention in this study includes the administration of propranolol by a physician specializing in burns and after consultation with the advice of a cardiologist orally or through the nasal tube with the same dose of 10 mg twice a day at 6 am and evening. Vital symptom control is routinely adjusted, and daily monitoring of hemodynamic status (heart rate and left hand blood pressure using non-invasive cuff measurements) is administered before drug administration in the intervention group and after drug administration routinely in both. The group is done in sections.
Category
Treatment - Drugs
2
Description
Control group: Burn patients are treated with standard burn care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaei Hospital
Full name of responsible person
Leili Yekefallah
Street address
Qazvin University of Medical Sciences, Bahonar,Qazvin,Iran
City
Qazvin
Province
Qazvin
Postal code
34411743148
Phone
+98 28 3333 6001
Email
Leili_fallah@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr.Mohammad Mahdi Emamjomeh
Street address
Qazvin University of Medical Sciences, Bahonar,Qazvin,Iran
City
Qazvin
Province
Qazvin
Postal code
3441343184
Phone
+98 28 3333 6001
Email
Apeymani@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Leili Yekefallah
Position
Assistant Professor of Qazvin Nursing School
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Qazvin University of Medical Sciences, Bahonar,Qazvin,Iran
City
Qazvin
Province
Qazvin
Postal code
34411743148
Phone
+98 28 3333 6001
Email
Leili_fallah@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Leili Yekefallah
Position
Assistant Professor of Qazvin Nursing School
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Qazvin University of Medical Sciences, Bahonar,Qazvin,Iran
City
Qazvin
Province
Qazvin
Postal code
3441341184
Phone
+98 0283338034
Email
Leili_fallah@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Leila Dehghankar
Position
Instructor of Qazvin Nursing School
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Qazvin University of Medical Sciences, Bahonar,Qazvin,Iran
City
Qazvin
Province
Qazvin
Postal code
3441341184
Phone
+98 28 3333 6001
Email
Dehghan247@gmail.com
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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The effect of propranolol on post-traumatic stress and clinical outcomes in burn patients
When the data will become available and for how long
6 months after printing the results
To whom data/document is available
Qazvin University of Medical Sciences Pregnancy Burn treatment centers
Under which criteria data/document could be used
Through a valid university site
From where data/document is obtainable
Qazvin- Qazvin University of Medical Sciences- School of Nursing and Midwifery
What processes are involved for a request to access data/document