Comparison of the mean pain experience during administration of normal and buffered lidocaine by inferior alveolar nerve block in children aged between 7 to 12 years old
1- Determining the average of pain score in patients during local anesthetic injection by regional block technique using normal lidocaine cartridge
2- Determining the average of pain score in patients during local anesthetic injection by regional block technique using buffered lidocaine cartridge
3- Comparing objective 1 and 2
Design
Clinical trials with control group, randomized triple blind, prospective, and crossover
Settings and conduct
The study will be conducted in pediatric dentistry department of Isfahan Dentistry faculty.
Participants/Inclusion and exclusion criteria
Criteria of inclusion for the samples:
1. Samples are selected from 7 to 12 year old patients referring to the specialized department of pediatric dentistry who need similar dental treatment on both sides of the mandible and at least two dental visits.
2. Only patientsare chosen who are classified as level three and four (positive and completely positive) of Frankl's behavioral classification.
3. Patients should not have any systemic problems, mental and physical disabilities, or any history of allergies to lidocaine and sulfite.
Exclusion criteria for the samples:
1. Patients whose parents are reluctant to participate in the study are excluded.
2. Teeth that have a local or diffused infection (abscess or cellulitis).
3. Patients who are agitated because of severe dental pain.
4. Children who have any oral lesions (such as aphthous ulcer, mucositis, etc.) in the anesthetic injection site.
Intervention groups
In intervention group 1 ml of Lidocaine 2% solution in combination with 0.2 ml solution of sodium bicarbonate 8.4% solution will be used and in control group lidocaine 2% solution will be used for mandibular local anesthetic with block technique respectively.
Main outcome variables
Pain during injection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170722035235N2
Registration date:2018-07-28, 1397/05/06
Registration timing:prospective
Last update:2018-07-28, 1397/05/06
Update count:0
Registration date
2018-07-28, 1397/05/06
Registrant information
Name
َAlireza Eshghi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 5591
Email address
eshghi@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2018-10-23, 1397/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the mean pain experience during administration of normal and buffered lidocaine by inferior alveolar nerve block in children aged between 7 to 12 years old
Public title
Comparison of the mean pain experience during administration of normal and buffered lidocaine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Only patients are chosen who are classified as level three and four (positive and completely positive) of Frankl's behavioral classification.
Patients are selected when their parents are willing to participate in the study after being informed by the consent form.
Patients should not have any systemic problems, mental and physical disabilities, or any history of allergies to lidocaine and sulfite.
Exclusion criteria:
Patients whose parents are reluctant to participate in the study are excluded.
Teeth that have a local or diffused infection (abscess or cellulitis).
Patients who are agitated because of severe dental pain.
Age
From 7 years old to 14 years old
Gender
Both
Phase
4
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The distribution of the patients in the control and intervention groups is performed using a randomized simple sampling method using random numbers table.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The individual giving the local anesthetic injection, the patient, and the Statistics expert do not know which group of intervention or control the patient is.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Department of Pediatric Dentistry, School of Dentistry, Hezar Jerib St, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174884841
Approval date
2018-07-11, 1397/04/20
Ethics committee reference number
IR.MUI.REC.1397.300199
Health conditions studied
1
Description of health condition studied
Comparison of the mean pain experience during administration of local anesthesia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain score using Visual Analog Scale
Timepoint
Measuring the pain score during injection
Method of measurement
Using the Visual Analog Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:
Category
Treatment - Drugs
2
Description
Control group:
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan University of Medical Sciences
Full name of responsible person
Hamid Mosleh
Street address
Department of Pediatric Dentistry, School of Dentistry, Hezar Jerib St, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174884841
Phone
+98 31 3777 2822
Email
mosleh_hamid@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Omid Savabi
Street address
بخش دندانپزشکی کودکان،دانشکده دندانپزشکی اصفهان، دانشگاه علوم پزشکی اصفهان، خیابان هزار جریب
City
Isfahan
Province
Isfehan
Postal code
8174884841
Phone
+98 31 3777 2822
Email
mosleh_hamid@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Dr Mehdi Jafarzadeh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Department of Pediatric Dentistry, School of Dentistry, Hezar Jerib St, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174884841
Phone
+98 31 3777 2822
Email
mejsamani@yahoo.co.uk
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Mehdi Jafarzadeh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Department of Pediatric Dentistry, School of Dentistry, Hezar Jerib St, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174884841
Phone
+98 31 3777 2822
Email
mejsamani@yahoo.co.uk
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamid Mosleh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Department of Pediatric Dentistry, School of Dentistry, Hezar Jerib St, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174884841
Phone
+98 31 3777 2822
Email
mosleh_hamid@yahoo.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
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