The comparison of anesthesia caused by lidocaine injection and lidocaine push with Diphenhydramine injection and Diphenhydramine push in the healing of head and face laceration
The Comparison of anesthesia caused by lidocaine injection or lidocaine push with diphenhydramine injection or diphenhydramine push in the healing of head and face laceration.
Design
Only the researcher is aware of the content of syringes which is used. To create anesthesia, 5 cc of 2% lidocaine and an ampoule of 50 ml of Diphenhydramine in 1 cc mixed with 4 cc of distilled water will be used. In order to eliminate the selection bias, patients with a history of specific and chronic diseases such as diabetes and connective tissue, etc., which delay healing, will be excluded from the study.
Settings and conduct
This study is a double-blind interventional study. In the diphenhydramine group, if the patient's pain is not controlled, the patient will be excluded from the study and the treatment will be continued according to the department's protocol.The data is consist of age, sex, location, length of laceration, scale of pain with VAS system.The size and the location of the laceration will be equalized in all 4 groups.
Participants/Inclusion and exclusion criteria
Traumatic patients with cerofacial lacerations with GCS=15. Patients who did not give the permission or have allergic reaction to Lidocaine or Diphenhydramin are excluded from study.
Intervention groups
In one group lidocaine is injected in the margin of wound. Dyphenhydramin is the other medicine which will be injected in second group. For the third group lidocaine will be pushed around the margin of the wound and for the forth group pushing process will be done with diphenhydramin. After 5 minutes we will start the suture of wound. Pain scaling will be done by VAS (Visual Analog Scale) system.
Main outcome variables
Pain during anesthesia
Pain during suturing
General information
Reason for update
Acronym
ED
IRCT registration information
IRCT registration number:IRCT20110814007327N9
Registration date:2023-10-29, 1402/08/07
Registration timing:registered_while_recruiting
Last update:2023-10-29, 1402/08/07
Update count:0
Registration date
2023-10-29, 1402/08/07
Registrant information
Name
Samad Shams Vahdati
Name of organization / entity
Tabriz University of Medical Scinces
Country
Iran (Islamic Republic of)
Phone
+98 41 1658 1401
Email address
shams@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-22, 1402/07/30
Expected recruitment end date
2023-11-21, 1402/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of anesthesia caused by lidocaine injection and lidocaine push with Diphenhydramine injection and Diphenhydramine push in the healing of head and face laceration
Public title
The comparison of anesthesia caused by lidocaine injection and/or lidocaine push with Diphenhydramine injection and/or Diphenhydramine push in the healing of head and face laceration.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Traumatic patients who are in the age of 18 to 60 years with GCS=15 with head and/or face laceration
Exclusion criteria:
the patients who did not give permission
allergy
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
After obtaining informed consent from patients, using Excel randomization software, patients are entered into 4 groups of 50 patients in parallel using a table of random numbers. Medicines and numbered syringes that only the researcher is aware of are used. In one group, lidocaine is injected around the wound. In one group, diphenhydramine is injected around the wound. In the third group, lidocaine is placed in the wound bed and margin, and in the fourth group, diphenhydramine is placed in the wound bed and margin. After five minutes have passed and anesthesia has taken effect, we will apply stitches. Pain intensity will be evaluated based on VAS. Data including age and sex, wound location, wound length and pain intensity will be collected based on VAS.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the patient is unaware of the type and name of the drug, and the person who will analyze the data will also be unaware of which drug and how the drug is administered, but the doctor, researcher, and nurse are aware of the data. and the results will be informed
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Tabriz University of Medical Sciences
Street address
Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
۵۱۵۶۸۳۴۵۶۳
Approval date
2023-04-25, 1402/02/05
Ethics committee reference number
IR.TBZMED.REC.1402.061
Health conditions studied
1
Description of health condition studied
head and/or face laceration
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pain
Timepoint
Before process, during the injection of anesthesia, At the time of stitching
Method of measurement
VAS scaling
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Traumatic patients with cerofacial lacerations with GCS=15. Patients who did not give the permission or have allergic reaction to Lidocaine or Diphenhydramin are excluded from study.Among the groups, the patients will be matched in terms of age and sex, so that after obtaining informed consent from the patients, using Excel randomization software, the patients will be entered into 4 groups of 50 people.Community Verified icon In one group Lidocaine is injected in the margin of wound. Dyphenhydramin is the other medicine which will be injected in second group. For the third group Lidocaine will be pushed around the margin of the wound and for the forth group pushing process will be done with Diphenhydramin. After 5 minutes we will start the suture of wound. Pain scaling will be done by VAS system.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
emergency of EmamReza hospital
Full name of responsible person
Samad Shams vahdati
Street address
Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
۵۱۵۶۸۳۴۵۶۳
Phone
+98 41 3335 2078
Email
sshamsv@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Samad Shams vahdati
Street address
Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
۵۱۵۶۸۳۴۵۶۳
Phone
+98 41 3335 2078
Email
sshamsv@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Samad Shams vahdati
Position
دانشیار طب اورژانس
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
۵۱۵۶۸۳۴۵۶۳
Phone
+98 41 3335 2078
Email
sshamsv@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Samad Shams vahdati
Position
Assosiated Professor of Emergency Medicine
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Tabriz University of Medical Sciences, Golgasht Street,
City
Tabriz
Province
East Azarbaijan
Postal code
۵۱۵۶۸۳۴۵۶۳
Phone
+98 41 3335 2078
Email
shams@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Samad Shams Vahdati
Position
Assosiated Professor of Emergency Medicine
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Tabriz University of Medical Sciences, Golgasht Street,
City
Tabriz
Province
East Azarbaijan
Postal code
5156834563
Phone
+98 41 3335 2078
Email
sshamsv@gmail.com
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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
all data after analysis will be published as an article
When the data will become available and for how long
one year after publication
To whom data/document is available
all researchers
Under which criteria data/document could be used
for metanalysis and systematic review
From where data/document is obtainable
send mail to sshamsv@gmail.com
What processes are involved for a request to access data/document