The Addition of Clonidine to the Articaine/Epinephrine for Inferior Alveolar Nerve Block Reduces Postoperative Pain of Patients with Irreversible Pulpitis: A Randomized Clinical Trial
Determining and comparing the mean pain score at different times in the first 72 hours after endodontic treatment using articaine-epinephrine combination with and without clonidine
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 per 100 patients, dice were used for randomization
Settings and conduct
The study site is Isfahan School of Dentistry. The contents of the carpules are prepared by a dental student and are labeled on the carpule containing clonidine number 1 and on the carpule containing placebo 2. The endodontist rolls the dice immediately before the injection and injects the carpules with number 1 if it is individual and the carpules with number 2 if it is even. The content of carpules was not determined until after the analysis
Participants/Inclusion and exclusion criteria
Patient with a mandibular molar tooth with asymptomatic irriversible pulpitis
Intervention groups
Intervention group received 0.2 ml of clonidine with carpol with a volume of 1.8 ml containing articaine 4% and epinephrine 1: 100,000
The control group received 0.2 ml of distilled water with carpol with a volume of 1.8 ml containing articaine 4%and epinephrine 1: 100,000
Main outcome variables
VAS pain score
General information
Reason for update
Acronym
IANB
IRCT registration information
IRCT registration number:IRCT20201031049199N1
Registration date:2020-11-17, 1399/08/27
Registration timing:retrospective
Last update:2020-11-17, 1399/08/27
Update count:0
Registration date
2020-11-17, 1399/08/27
Registrant information
Name
Sara Hashemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3669 1568
Email address
sara_hsh76@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-12, 1396/07/20
Expected recruitment end date
2018-02-09, 1396/11/20
Actual recruitment start date
2017-11-01, 1396/08/10
Actual recruitment end date
2018-03-11, 1396/12/20
Trial completion date
2018-03-11, 1396/12/20
Scientific title
The Addition of Clonidine to the Articaine/Epinephrine for Inferior Alveolar Nerve Block Reduces Postoperative Pain of Patients with Irreversible Pulpitis: A Randomized Clinical Trial
Public title
Addition of clinidine to articaine solution in pain relief after root canal treatment
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Aged 15-60
ASA grade I
Have symptomatic irreversible pulpitis in a mandibular posterior tooth
Exclusion criteria:
necessity for multi-visit treatments
consumption of analgesics or opioids in a week
periodontal problems
underlying diseases such as diabetes, hypertension or other cardiovascular diseases
an allergy or contraindication to clonidine, articaine, or epinephrine
active signs of oral infection or inflammation
Pregnant or lactating mothers
drug abusers, and patients taking a β-blocker
Age
From 15 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Actual sample size reached:
96
Randomization (investigator's opinion)
Randomized
Randomization description
The clonidine-containing and non-clonidine cartridges were labelled No. 1 and No. 2, respectively. The solutions were prepared daily under aseptic conditions .Immediately before the injection, the endodontist, who was unaware of the contents of the cartridges, threw a dice. A No. 1 cartridge was used when an odd number came out and a No. 2 cartridge was used with an even number. Therefore, both the patient and the investigator were not aware of the content of the injected solution.
Blinding (investigator's opinion)
Double blinded
Blinding description
the anesthetic solutions were prepared and encoded by a dental student who was not involved in the study. Endodontist used a dice to choose which vial to use. The content of each number was not explained untill the data analysis was done.
Placebo
Used
Assignment
Parallel
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
Hezar Jerib St., Isfahan University of Medical Sciences, Building No. 4 - Vice Chancellor for Research and Technology
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Approval date
2017-10-02, 1396/07/10
Ethics committee reference number
IR.MUI.REC.1396.3.272
Health conditions studied
1
Description of health condition studied
Post operative pain
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain
Primary outcomes
1
Description
Pain score
Timepoint
12 h after- 24 h after-36 h after- 48 h after-72 h after procedure
Method of measurement
Heft- parker visual analog scale
Secondary outcomes
1
Description
Heart rate
Timepoint
Immediately Before administration- 5 minutes after administration
Method of measurement
digital blood pressure monitor (M3, Omron, omron healthcare co MTD, japan)
Intervention groups
1
Description
Intervention group: The clonidine group (Articaine + Epinephrine + Clonidine, n = 50) received an IANB with 0.2 ml clonidine (Catapressan amp., 150 µg/ml; BoehringerIngelheim, Ingelheim am Rhein, Germany) in addition to 1.8 ml of 4% articaine (Daropakhsh, Tehran, Iran) with 1:100,000 epinephrine.
Category
Prevention
2
Description
Control group: The control group (Articaine + Epinephrine, n = 50) received an IANB with 0.2 ml distilled water in addition to 1.8 ml 4% articaine with 1:100,000 epinephrine (Daropakhsh, Tehran, Iran)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dentistry facilty of Isfahan University of Medical Sciences
Full name of responsible person
Elham Shadmehr
Street address
Shohadaye sofe St
City
Isfahan
Province
Isfehan
Postal code
87986546
Phone
+98 31 3440 8524
Email
elham.shadmer@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Shaghayegh Haghjoo
Street address
Isfahan University of Medical Sciences, Hezar jarib St
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Web page address
https://research.mui.ac.ir/
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.Elham Shadmehr
Position
Assistant professor of endodontic, Isfahan University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Hezar jarib St
City
Isfahan
Province
Isfehan
Postal code
87986546
Phone
+98 31 3440 8524
Email
elham.shadmer@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr.Elham Shadmehr
Position
Assistant professor of endodontic, Isfahan University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dentistry faculty of Isfahan University of Medical Sciences, Hezar jarib St
City
Isfahan
Province
Isfehan
Postal code
87986546
Phone
+98 31 3440 8524
Email
elham.shadmer@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sara Hashemi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
3rd Ave, South Resalat St, Sheikh koleini St
City
Isfahan
Province
Isfehan
Postal code
۸۱۶۸۹۶۴۳۳۳
Phone
+98 31 3669 1568
Email
Sara_hsh76@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
VAS pain score and hemodynamic factors are shareable
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
The data will be available to researchers working in scientific institutes.
Under which criteria data/document could be used
Data can be used if it is not in conflict with interests.
From where data/document is obtainable
Sara Hashemi
09134205038
Sara_hsh76@yahoo.com
No. 32, 3rd Alley, 3rd Alley, South Resalat St., Sheikh Kolini St., Isfahan, Iran Postal Code: 8168964333
What processes are involved for a request to access data/document
Email official documents related to the data requirements for a scientific project. Will be answered in a week.