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The effect of administrating a sacarose solution and cooling on Anxiety and Pain during Inferior Alveolar Nerve Block in Children Aged 7 to 11 Years: A Randomized Clinical Trial

Protocol summary

Study aim
Investigating the effect of the use of sucrose solution and cold on pain and anxiety during inferior alveolar nerve block anesthesia in children aged 7 to 11 years.
Design
A total of 60 patients will be selected among those who were referred to the pediatric department of Shahid Sadoughi Dental School in Yazd Group 1: Cold Group 2: 30% sucrose solution Also, on the opposite side of the jaw in both groups, 20% benzocaine gel is applied as a control group. Randomization to determine the group, as well as the right or left side of each jaw, is done in two steps and by the sealed envelope method.
Settings and conduct
This study will be conducted in Shahid Sadoughi Faculty of Dentistry, Yazd. In the first group, ice pieces are placed in the injection site for 2 minutes. In the second group, patients keep 10 ml of 30% sucrose solution in their mouth and spit after 2 minutes. On the opposite side of the jaw in both groups, 20% benzocaine gel is applied. Then the alveolar nerve block injection will be done.
Participants/Inclusion and exclusion criteria
Inclusion criteria: the presence of caries in the mandibular primary teeth that require bilateral inferior alveolar block injection, no history of intraoral injection, no allergy to lidocaine, no history of pain due to pulp inflammation, being cooperative, not having unsuccessful experience with medical treatments. Patients with a history of abscess, redness and fistula at the injection site are excluded from the study.
Intervention groups
In the first group, ice pieces are placed at the injection site for 2 minutes. In the second group, patients keep 10 ml of 30% sucrose solution in their mouth and spit after 2 minutes. On the opposite side in both groups, benzocaine gel is applied.
Main outcome variables
Determining an effective intervention to reduce pain and anxiety of 7-11-year-old children before dental anesthesia injection

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240224061096N1
Registration date: 2024-05-11, 1403/02/22
Registration timing: registered_while_recruiting

Last update: 2024-05-11, 1403/02/22
Update count: 0
Registration date
2024-05-11, 1403/02/22
Registrant information
Name
Maryam Irannezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 4220 1058
Email address
m.irannezhad@stu.ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-11, 1403/02/22
Expected recruitment end date
2024-07-20, 1403/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of administrating a sacarose solution and cooling on Anxiety and Pain during Inferior Alveolar Nerve Block in Children Aged 7 to 11 Years: A Randomized Clinical Trial
Public title
The effect of administrating a sacarose solution and cooling on Anxiety and Pain during Inferior Alveolar Nerve Block in Children Aged 7 to 11 Years: A Randomized Clinical Trial
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The presence of caries in the mandibular primary teeth that require bilateral inferior alveolar block injection No history of intraoral injection No allergy to lidocaine No history of pain due to pulp inflammation Being cooperative Not having unsuccessful experience with medical treatments
Exclusion criteria:
Children diagnosed with anxiety disorder will be excluded from the study. Patients with a history of abscess, redness and fistula at the injection site are excluded from the study.
Age
From 7 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
For the random allocation of children to two study groups, the method of random allocation of the sequence of random numbers generated by the Random Allocation software will be used. The same method is also used to determine which side of the jaw will be treated as intervention or control.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Faculty of Dentistry, Shahid Sadougi University of Medical Sciences, Yazd
Street address
Shahid Dr. Bahner Square, Central Organization of Shahid Sadougi University of Medical Sciences and Healthcare Services, Yazd.
City
Yazd
Province
Yazd
Postal code
8916978477
Approval date
2023-12-24, 1402/10/03
Ethics committee reference number
IR.SSU.DENTISTRY.REC.1402.063

Health conditions studied

1

Description of health condition studied
Inferior Alveolar Nerve Block
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Anxiety during Inferior Alveolar Nerve Block
Timepoint
Before and during anesthesia injection
Method of measurement
FIS (Facial Image Scale), Blood pressure, Pulse rate

2

Description
Pain during Inferior Alveolar Nerve Block
Timepoint
Before and during anesthesia injection
Method of measurement
WBFPS (Wong-Baker Faces Pain related Scale), FLACC (Face, Legs, Activity, Cry, Controllability scale)

Secondary outcomes

empty

Intervention groups

1

Description
First intervention group: cold. The ice pieces are placed at the injection site for 2 minutes.
Category
Other

2

Description
Second intervention group: sucrose solution 30%. Patients keep 10 ml of 30% sucrose solution (made in the pharmacology department of Shahid Sadoughi University of Medical Sciences) in their mouth and spit after 2 minutes before injection.
Category
Other

3

Description
Control group: Benzocaine gel. On the opposite side of the mouth in both intervention groups, benzocaine 20% gel (PRODOFIX topical anesthetic gel 20% – Iran) is applied before injection.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Pediatric faculty of dental school of Shahid Sadoughi University of medical science
Full name of responsible person
Maryam Irannezhad
Street address
Dahe Fajr boulevard, Imam Reza Square, Shahid Sadoughi Faculty of Dentistry
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 913 178 3358
Email
m.irannezhad@stu.ssu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Maryam Irannezhad
Street address
Dahe Fajr boulevard, Imam Reza Square, Shahid Sadoughi Faculty of Dentistry
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3620 4760
Email
international@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Maryam Irannezhad
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
No 15 (Niloufar) Ave, Meghdad st, Mascan o shahrsazi square
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 34 4220 1058
Fax
Email
m.irannezhad@stu.ssu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Maryam Irannezhad
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
No 15 (Niloufar) Ave, Meghdad st, Mascan o shahrsazi square
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 34 4220 1058
Fax
Email
m.irannezhad@stu.ssu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Maryam Irannezhad
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
No 15 (Niloufar) Ave, Meghdad st, Mascan o shahrsazi square
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 34 4220 1058
Fax
Email
m.irannezhad@stu.ssu.ac.ir

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
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