Specific goals
1- Determining the mean Visual Analogue Scale (VAS) after the needle insertion in the benzocaine group
2- Determining the mean VAS after the needle insertion in the Caine P group
3- Comparison of VAS means after needle insertion in benzocaine and Caine P group
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 23 patients. Randomization will be done with Random allocation software.
Settings and conduct
The intervention is performed during 2 sessions. The Visual analog scale will be explained to the patient before starting.
The desired areas will be dried with air for 5 seconds.
With a cotton swab benzocaine will be applied, and in the next session, with the same preparation on the other side, Caine P will be applied.
(The test is double-blind, and the patient and the dentist do not know which anesthesia was applied on which side.)
5 minutes after local anesthesia, the injection will be given for palatal anesthesia. After the injection, VAS scale is shown to the patient to rate their pain
Participants/Inclusion and exclusion criteria
Inclusion criteria include children who:
1- They are 9 to 12 years old.
2- They need to inject palatal anesthesia on both sides of the jaw.
3- Written consent was obtained from their parents.
4- They are cooperative.
5- They are systemically healthy.
Exclusion criteria included children who:
1- With dissatisfaction and termination of cooperation.
2- Has an underlying disease such as allergies to anesthesia, epilepsy, asthma, etc.
3- At the age of less than 9 years or more than 12 years.
Intervention groups
Intervention group: Patients receiving Caine P as local anesthesia before palatal anesthesia injection
Control group: Patients receiving benzocaine as local anesthesia before palatal anesthesia injection
Main outcome variables
Needle entry pain before palatal anesthesia injection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220412054516N1
Registration date:2022-05-08, 1401/02/18
Registration timing:prospective
Last update:2022-05-08, 1401/02/18
Update count:0
Registration date
2022-05-08, 1401/02/18
Registrant information
Name
Mostafa Akbari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3370 0429
Email address
mostafa.akbari@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2022-06-22, 1401/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparison study of the effects of Caine P with topical benzocaine in reducing needle insertion pain in Palatal anesthesia in children 9 to 12 years
Public title
Comparison of the effect of Caine P with topical benzocaine on reducing needle entry pain in palatal anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children 9 to 12 years
Children who need palatal anesthesia injections on both sides of the jaw
Written consent was obtained from their parents
They are cooperative
They are systemically healthy
Exclusion criteria:
At risk for Methemoglobinemia
Allergic to benzocaine, lidocaine and prilocaine
Age
From 9 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
23
More than 1 sample in each individual
Number of samples in each individual:
2
One quadrant receiving the intervention (Caine P) and one quadrant receiving the control (benzocaine)
Randomization (investigator's opinion)
Randomized
Randomization description
After selecting the samples with inclusion criteria and without exclusion criteria, the quadrants were divided into two groups by blocking method. Randomization was performed with Random allocation software. Based on this, 23 double blocks were created with the mentioned software and provided to the main executor.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient and the dentist performing the treatment do not know which anesthesia was applied on which side.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandran University of Medical Sciences
Street address
Deputy of Research and Technology, Moallem Square, Sari
City
Sari
Province
Mazandaran
Postal code
4815733971
Approval date
2022-01-12, 1400/10/22
Ethics committee reference number
IR.MAZUMS.REC.1400.638
Health conditions studied
1
Description of health condition studied
Needle entry pain before palatal anesthesia injection
ICD-10 code
Y65.8
ICD-10 code description
Other specified misadventures during surgical and medical care
Primary outcomes
1
Description
Pain after needle insertion before palatal anesthesia injection
Timepoint
5 minutes after applying the local anesthetic cream
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: quadrant receiving Caine P as local anesthesia before injection = with a cotton swab on one side of the jaw Caine P (2.5% lidocaine cream and 2.5% perilocaine similar to EMLA, product of IranNajo) will be applied by the injector. Injection will be done 5 minutes after local anesthesia with 2% lidocaine (manufactured by Daru Pakhsh) with a 30 gauge needle (manufactured by DENJECT) in a 3 mm area of the free gingival margin and that the needle's bevel is facing the bone, and the needle goes inside the tissue till it is in contact with bone. The injection is given to achieve palatal anesthesia. After the injection, the VAS scale is shown to the patient to indicate the amount of pain. Measurements with the VAS will be performed only once per session. The average of these numbers will be recorded and the data will be analyzed.
Category
Treatment - Drugs
2
Description
Control group: quadrant receiving Benzocaine as local anesthesia before injection = with a cotton swab on one side of the jaw benzocaine (20% benzocaine gel from Master dent) will be applied by the injector. Injection will be done 5 minutes after local anesthesia with 2% lidocaine (manufactured by Daru Pakhsh) with a 30 gauge needle (manufactured by DENJECT) in a 3 mm area of the free gingival margin and that the needle's bevel is facing the bone, and the needle goes inside the tissue till it is in contact with bone. The injection is given to achieve palatal anesthesia. After the injection, the VAS scale is shown to the patient to indicate the amount of pain. Measurements with the VAS will be performed only once per session. The average of these numbers will be recorded and the data will be analyzed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Touba Dental Clinic
Full name of responsible person
Doctor Abbas Mesgrani
Street address
Touba Dental Clinic, Khazar Square, Sari
City
Sari
Province
Mazandaran
Postal code
-
Phone
+98 11 3324 0003
Email
name@domain.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Pedram Ebrahimnejad
Street address
The headquarters of Mazandaran University of Medical Sciences, Beginning of Valiasr Highway, Imam Square, Sari
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 11 3304 4000
Email
ravabetomoomi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Mehdi Taghian
Position
Assistant Professor and Faculty Member of Mazandaran University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Office Unit 610, 6th Floor, Shahriar 3 Building, Farhang St, Sari
City
Sari
Province
Mazandaran
Postal code
-
Phone
+98 11 3330 5443
Email
m.taghian@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mehdi Taghian
Position
Assistant Professor and Faculty Member of Mazandaran University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Office Unit 610, 6th Floor, Shahriar 3 Building, Farhang St, Sari
City
Sari
Province
Mazandaran
Postal code
-
Phone
+98 11 3330 5443
Email
m.taghian@mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mostafa Akbari
Position
Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Rose Gold, Golestan 2 Ave, Farahabad Blvd, Sari
City
Sari
Province
Mazandaran
Postal code
4816996744
Phone
+98 11 3370 0429
Email
mostafa.akbari@mazums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
Part of the data, such as information about the main outcome or the like, can be shared
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Study documents will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
The use of data to carry out new research projects is permitted
From where data/document is obtainable
To the e-mail address of the respondent, Mostafa Akbari:
mostafa.akbari@mazums.ac.ir
What processes are involved for a request to access data/document
After reviewing the incoming emails, the data will be sent to the applicant.