The effect of tactile or visual determination of injection site on subjective and objective pain reactions and success rate of inferior alveolar nerve block in children
One of the most important aspects of behavior management in pediatric dentistry is pain control. The purpose of this study is the effect of tactile or visual determination of injection site on subjective and objective pain reactions and success rate of inferior alveolar nerve block in children. In this double blind randomized clinical trial, 40 children 7-9 years old who need mandibular second primary molars pulpotomy, with no previous dental history and no emergency mode or pulp origin tooth pain, will participate. Slit mouth design will be used in this study, in a way that each child will operate as a self–control and they will be randomly assigned, by the toss of a coin, to receive either tactile or visual mandibular nerve block methods. To make block anesthesia with tactile method is being used of touching coronoid notch for determination of needle insertion site and for visual method, the observation of tip of pterygomandibular triangle is being used. The interval time between two visits will be a week. In second visit, child will received the determination of needle insertion site method that is not used before. Objective pain during injection by the Sound Eyes Motor scale (SEM), subjective pain during injection by Facial Image Scale (FIS) and the success of anesthesia in access cavity preparation by the SEM will be recorded for each two injections. Child and the experimenter of objective pain and success rate of anesthesia will be unaware of determination of needle insertion site method.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT201605116105N5
Registration date:2016-06-02, 1395/03/13
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-06-02, 1395/03/13
Registrant information
Name
Nahid Ramazani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 1341 6706
Email address
ramazani77@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Zahedan University of Medical Sciences
Expected recruitment start date
2016-09-09, 1395/06/19
Expected recruitment end date
2016-10-10, 1395/07/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of tactile or visual determination of injection site on subjective and objective pain reactions and success rate of inferior alveolar nerve block in children
Public title
The effect of tactile or visual determination of injection site on subjective and objective pain reactions and success rate of inferior alveolar nerve block in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: children between 7-9 years old, require treatment in the mandibular second primary molar, a full physical and mental health, located in the classification of Frankel positive or definitely positive during behavioral assessment before treatment, identified the pterygomandibular triangle landmark in intraoral examination.
Exclusion criteria: previous dental history, allergies to medication or anesthetic, emergency mode or pulp origin tooth pain, no need to premedication before dental treatment.
Age
From 7 years old to 9 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Crossover
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
Pardis Department of Zahedan University of Medical Sciences, Khalije Fars Boulvard, Dr.Hesabi Square, Zahedan
City
Zahedan
Postal code
9816743463
Approval date
2015-04-19, 1394/01/30
Ethics committee reference number
IR.ZAUMS.rec.1394.32
Health conditions studied
1
Description of health condition studied
Local anesthesia,
ICD-10 code
Y48.3
ICD-10 code description
Local anaesthetics
Primary outcomes
1
Description
Objective and subjective pain reaction
Timepoint
During injection and after intervention 1 and 2
Method of measurement
Using SEM scale and using FIS
Secondary outcomes
1
Description
Success of anesthesia
Timepoint
During access cavity preparation, after intervention 1 and 2 and 5 minutes waiting period
Method of measurement
Using SEM scale
Intervention groups
1
Description
Intervention 1:
Applying topical anesthesia gel (TOPEX, Sultan Healthcare IND. CO, USA) by cotton applicator at the injection site on dried mucosa for 60 seconds, administration mandibular block anesthesia by using visual method to find the needle insertion site by delivering 1 ml of lidocaine %2 with epinephrine1:80000 (Persocaine-E, Darou Pakhsh IND. CO, Iran) with temperature of 21 °C by using Anthogyr syring (France) with needle guage 27 and length of 35mm (C- KJECT, CK DENTAL IND. CO, Korea) within 1.5 minutes.
Category
Treatment - Other
2
Description
Intervention 2:
Applying topical anesthesia gel (TOPEX, Sultan Healthcare IND. CO, USA) by cotton applicator at the injection site on dried mucosa for 60 seconds, administration mandibular block anesthesia by using tactile method to find the needle insertion site by delivering 1 ml of lidocaine %2 with epinephrine 1:80000 (Persocaine-E, Darou Pakhsh IND. CO, Iran) with temperature of 21 °C by using Anthogyr syringe (France) with needle guage of 27 and length of 35mm (C- KJECT, CK DENTAL IND. CO, Korea) within 1.5 minutes.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric Department, Zahedan dentistry School
Full name of responsible person
Nahid Ramazani
Street address
Zahedan dentistry School, Azadegan East Street, Zahedan
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research, Zahedan University of Medical Sciences
Full name of responsible person
Houshang Rafighdoost
Street address
Pardis Department of Zahedan University of Medical Sciences, Khalije Fars Boulvard, Dr.Hesabi Square, Zahedan
City
Zahedan
Grant name
7167
Grant code / Reference number
7167
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research, Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan dentistry School
Full name of responsible person
Nahid Ramazani
Position
Associate Professor
Other areas of specialty/work
Street address
Zahedan dentistry School, Azadegan East Street, Zahedan
City
Zahedan
Postal code
9817699693
Phone
+98 54 3342 3218
Fax
-
Email
ramazani_nahid@yahoo.com
Web page address
-
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan dentistry School
Full name of responsible person
Nahid Ramazani
Position
Associate Professor
Other areas of specialty/work
Street address
Zahedan dentistry School, Azadegan East Street, Zahedan
City
Zahedan
Postal code
9817699693
Phone
+98 54 3342 3218
Fax
-
Email
ramazani_nahid@yahoo.com
Web page address
-
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)