Evaluation of analgesic effect of diluted lidocaine spray in reducing pain caused by burning debridement in burning patients admitted to Ali-ebn Abitaleb Hospital in Zahedan between 2022 and 2023
Determining the analgesic effect of diluted lidocaine spray in reducing pain caused by burn debridement in patients hospitalized in the burn department of Ali Ibn Abi Talib Zahedan Hospital.
Design
This study is an interventional type, the study subjects include all patients hospitalized in the burn department of Ali Bin Abi Talib Zahedan Hospital, and they are randomly selected. After entering the study and obtaining consent, demographic and basic information is recorded for all patients
This study is a single-blind randomized clinical trial. All patients who meet the entry criteria at the time of the study are considered to enter this study. After obtaining a written consent form and explaining the conditions of the study, the patients are asked to rate their pain level based on the VAS scale. Then they are randomly entered into each of the investigated groups.
Settings and conduct
In the control group, and in the intervention group, lidocaine spray will be prescribed for the patients. Then, each patient is numbered
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Informed and free consent to participate in the study
2. Burn severity above 10%
3. Patients hospitalized in the burn department of Ali Bin Abi Talib Zahedan Hospital
Exit criteria:
1. Impaired level of consciousness
2. Hemodynamic disorder
3. Taking drugs or alcohol or pain relievers or painkillers in the last 48 hours.
4. History of taking MAOI, TCA, SSRI, phenothiazines or sleeping pills
5. Suffering from chronic diseases
6. Having asthma
7. Allergy to lidocaine and pethidine
8. Weight more than 100 kg
9. Lack of consent to enter the study
10. Non-cooperation of the patient
Intervention groups
blood pressure
• heart beat
• Respiration rate
• Oxygen saturation of arterial blood
• Age and sex
Pain based on VAS (0 to 10)
Main outcome variables
pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231126060194N1
Registration date:2024-02-14, 1402/11/25
Registration timing:retrospective
Last update:2024-02-14, 1402/11/25
Update count:0
Registration date
2024-02-14, 1402/11/25
Registrant information
Name
Amirali Divsalar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 4465 2488
Email address
amiralidivsalar@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-05, 1402/09/14
Expected recruitment end date
2024-02-09, 1402/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of analgesic effect of diluted lidocaine spray in reducing pain caused by burning debridement in burning patients admitted to Ali-ebn Abitaleb Hospital in Zahedan between 2022 and 2023
Public title
Evaluation of analgesic effect of diluted lidocaine spray in reducing pain caused by burning debridement in burning patients admitted to Ali-ebn Abitaleb Hospital in Zahedan between 2022 and 2023
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
1. Informed and free consent to participate in the study 2. Burn severity above 10% 3. Patients admitted to the burn department of Ali Bin Abi Talib Zahedan Hospital
Exclusion criteria:
1. Impaired level of consciousness (GCS < 15) 2. Hemodynamic disturbance during drug injection (SBP ≤ 90 and PR ≤ 60 and RR ≤ 8 and ≥ 90% (O2) and in patients with blood pressure (SBP ≤ 180) or (SBP ≤ 100) ) 3. Use of drugs or alcohol or sedatives or pain relievers in the last 48 hours 4. History of taking MAOI, TCA, SSRI, phenothiazines or sleeping pills 5. Suffering from chronic diseases (congenital or acquired heart diseases, heart failure chronic liver disease, biliary tract diseases, kidney failure and chronic lung disease) according to history and clinical examination 6. Asthma according to history and clinical examination 7. Allergy to lidocaine and pethidine 8. Weight more than 100 kg 9. Lack of consent to enter the study 10. Patient's lack of cooperation
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of patients to two groups is done by permuted block stratified randomization method. In this way, first, eligible referring patients are classified according to age and gender in the order of arrival. Then, based on blocks of 4 (consisting of two groups A and B and two repetitions for each) randomly selected from among all the possible states of permutations, they are assigned to the desired group (2). These blocks were created using statistical software R version 4.0.2
Blinding (investigator's opinion)
Single blinded
Blinding description
In this research, single blinding method is used. So that the patient will not be aware of the intended intervention.
Table 1: The practical method of assigning patients to two groups with the permutation block stratified randomization method
Age ≤ 30 > 30
gender male female male female
Groups BAAB
AABB
BAAB
ABBA
BBAA
ABAB
AABB
ABBA
ABBA
AABB ABAB
ABAB
BABA
BABA
BAAB
ABBA
ABAB
ABAB
BBAA
BAAB ABAB
AABB
AABB
ABBA
BBAA
AABB
BAAB
BABA
BBAA
AABB AABB
BAAB
BBAA
BABA
BAAB
AABB
ABBA
ABAB
BAAB
ABAB
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of zahedan university of medical sciences
Street address
Zahedan University of Medical Sciences Khalij -e- Fars Blvd, Zahedan, Sistan & Balouchestan Province, Islamic Republic of Iran
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2023-11-12, 1402/08/21
Ethics committee reference number
IR.ZAUMS.REC.1402.327
Health conditions studied
1
Description of health condition studied
Pain after a burn
ICD-10 code
G89.11
ICD-10 code description
Acute pain due to trauma
Primary outcomes
1
Description
Change in the amount of pain reported by the patient (pain measured by visual observation)
Timepoint
The pain level will be asked and recorded at times 0, 5, 10, 20, 30, and 60 minutes
Method of measurement
VAS criterion
Secondary outcomes
1
Description
Analgesia onset time in patients receiving lidocaine and IV pethidine
Timepoint
Time after starting to receive lidocaine (in minutes)
Method of measurement
Time in minutes
Intervention groups
1
Description
Intervention group: The group that receiving lidocaine medicine
Category
Treatment - Drugs
2
Description
Control group: The group that receiving pethidine drug
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali ebn abi taleb hospital of zahedan
Full name of responsible person
masoumeh abbasnejad
Street address
persian gulf Blvd,Ali ebn abitaleb hospital
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
11111111111
Phone
+98 911 207 6237
Email
Amiralidivsalar@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
dr.masoumeh abbasnejad
Street address
Zahedan University of Medical Sciences Khalij -e- Fars Blvd, Zahedan, Sistan & Balouchestan Province, Islamic Republic of Iran
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2151
Email
info@zaums.ac.ir
Web page address
https://zaums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
1
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
Zahedan University of Medical Sciences
Full name of responsible person
masoumeh abbasnjad
Position
Consultant, Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Zahedan University of Medical Sciences Khalij -e- Fars Blvd, Zahedan, Sistan & Balouchestan Province, Islamic Republic of Iran
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
0543337215
Email
Amiralidivsalar@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
masoumeh abbasnejad
Position
Consultant, Professo
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Zahedan University of Medical Sciences Khalij -e- Fars Blvd, Zahedan, Sistan & Balouchestan Province, Islamic Republic of Iran
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2151
Email
Amiralidivsalar@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
masoumeh abbasnejad
Position
Consultant, Professo
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Zahedan University of Medical Sciences Khalij -e- Fars Blvd, Zahedan, Sistan & Balouchestan Province, Islamic Republic of Iran
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2151
Email
Amiralidivsalar@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
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 after the results are printed
To whom data/document is available
It will be available for researchers working in academic and scientific institutions
Under which criteria data/document could be used
1- The goal should be clear
2- The possibility of using in future studies
From where data/document is obtainable
Amirali Divsalar
amiralidivsalar@gmail.com
Zahedan University of Medical Sciences Khalij -e- Fars Blvd, Zahedan, Sistan & Balouchestan Province, Islamic Republic of Iran
98-054-33372013
What processes are involved for a request to access data/document
You can request by sending an email, the documents will be sent within a maximum of one week