The purpose of this study was to determine the analgesic effects of intravenous laser in patients with grade 3 and b2 burns with a high percentage of 20%.
Design
The design of this study was a randomized clinical trial. Twenty patients with grade 3 and b2 burns with a high incidence of 20% after rendering were divided into two groups of control and treatment. The treatment group in addition to the standard treatment receives the dose of laser therapy and the control group receiving the inert dose laser. -
Settings and conduct
In this study, patients with burns hospitalized at Shahid Motahhari Hospital are randomly divided into two groups of laser and control. A non-physician performs randomization.People who fill in the pain questionnaire and record drug use and a person who is reviewed the results are unaware of laser and control groups.
Participants/Inclusion and exclusion criteria
The criteria for entering the study include patients aged 20-50 years old; patients with grade 3 and b2 burns with a higher than 20% degree; informed consent; exclusion criteria include chronic patients with continuous onset drug use; addicted people; women Pregnant; Cancer patients.
Intervention groups
laser group: are also treated with intravenous laser for 1 week in addition to daily routine therapy. For laser irradiation, red light is used, 655 nm, 10 mW, 10 jules.
control group:the laser is irritated with a non-therapeutic dose
Main outcome variables
The pain score of patients in both groups is measured and recorded for three to five days after starting treatment every 3 hours based on the Visual Analog Scale.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111121008146N16
Registration date:2018-01-02, 1396/10/12
Registration timing:registered_while_recruiting
Last update:2018-01-02, 1396/10/12
Update count:0
Registration date
2018-01-02, 1396/10/12
Registrant information
Name
Mohammadreza Razaghi
Name of organization / entity
Laser application in medical sciences research center
Country
Iran (Islamic Republic of)
Phone
+98 21 2271 8021
Email address
laser.cntr@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the analgesic effects of intravenous laser in burned patients with grade 3 and b2 and higher than 20%
Public title
The effect of intravenous laser in burned patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients aged 20-50 years
patients with grade 3 and b2 burns with a higher than 20%
informed consent
Exclusion criteria:
chronic patients with continuous onset drug use
addicted people
pregnant women
Cancer patients
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are assigned with simple and individual randomization into two groups of laser and control with 1: 1 random numbers table. A person other than the physician conducts randomization.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, those who fill in the pain questionnaire, record the drug intake, and examine the results.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Next to Ayatollah Taleghani Hospital, Shahid Arabi ST. Yemen street, Shahid Chamran highway, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Approval date
2017-10-29, 1396/08/07
Ethics committee reference number
IR.SBMU.RETECH.REC.1396.515
Health conditions studied
1
Description of health condition studied
burn with grade 3 and b2 and higher than 20%
ICD-10 code
L10-L14
ICD-10 code description
Bullous disorders
Primary outcomes
1
Description
Pain score of patients
Timepoint
Three to five days after starting treatment every 3 hours
Method of measurement
McGill questionnaire scoring system and VAS mark
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in the laser group receive routine daily treatment for 1 week with intravenous laser with red light, 655 nm, 10 mW, 10 jules.
Category
Treatment - Other
2
Description
Control group: They are treated with medicine plus non-therapeutic doses of shame laser.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Laser Application Research Center in Medical Sciences
Full name of responsible person
Dr.Mohammad Reza Razaghi
Street address
Shohadaye Tajrish Hospital, Tajrish, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 9221
Email
laser.cntr@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Zarghi
Street address
Next to Ayatollah Taleghani Hospital, Shahid Arabi ST. Yemen street, Shahid Chamran highway, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Email
laser.cntr@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,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
Laser Application Research Center in Medical Science
Full name of responsible person
Dr.Mohammad Reza Razaghi
Position
urologist
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Shohadaye Tajrish Hospital, Tajrish, Tehran
City
Teharn
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 9221
Fax
Email
laser.cntr@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Laser Application Research Centre in Medical Sciences
Full name of responsible person
Dr.Mohammad Reza Razaghi
Position
urologist
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Shohadaye Tajrish Hospital, Tajrish, Tehran
City
Teharn
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 9221
Fax
Email
laser.cntr@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Laser Application Research Centre in Medical Sciences
Full name of responsible person
Dr.Mohammad Reza Razaghi
Position
urologist
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Shohadaye Tajrish Hospital, Tajrish, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 9221
Fax
Email
laser.cntr@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available