Comparative Evaluation of the effect of lidocaine-ketorolac mixture and lidocaine on Inferior Alveolar Nerve Block anesthesia in patients with irreversible pulpitis
Patients pain management is a challenging factor in Endodontics. Appropriate managing of this pain can build a positive attitude among the patients. Studies have shown, if the amount of inflammatory factors reduces, the anesthesia success rate will be increased and the pain level will be decreased. Ketorolac is of the NSAIDs that has strong analgesic effect. The purpose of this study is to peruse lidocaine-ketorolac mixture effect on the success of inferior alveolar nerve block during the root canal treatment in patients who have Irreversible Pulpitis.
Design
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment.
Settings and conduct
The changed anesthetic cartridge will be coded and will be given to the endodontist. Finally, the root canal treatment procedure will be started while the dentist and the patient don't know the composition of anesthetic liquid.
Participants/Inclusion and exclusion criteria
Main inclusion criteria is symptomatic Irreversible pulpitis in lower molar teeth. The pain level should be more than 54 on Heft-Parker's index; Pregnancy, digestive disease and ASA III or IV are the most important factors for excluding patients from the study.
Intervention groups
Patients who involved in control group will be injected a conventional lidocaine 2% with epinephrin 1/100000 and another cartridge which 0.8 ml of that has been brought out and filled by normal saline; The patients who involved in intervention group will be recieved two injections too. The first injection consists of conventional lidocaine 2% with epinephrin 1/100000 and the second injection has 0.8 ml of ketorolac 30mg/ml instead of lidocaine.
Main outcome variables
Finding better solution for managing the pain in patients who suffer from irreversibile pulpitis; Improving patients attitude to dental procedures.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181104041542N1
Registration date:2019-01-18, 1397/10/28
Registration timing:prospective
Last update:2019-01-18, 1397/10/28
Update count:0
Registration date
2019-01-18, 1397/10/28
Registrant information
Name
Hessamoddin Faghihian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3651 6128
Email address
hesamfgh95@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-01, 1397/11/12
Expected recruitment end date
2019-04-18, 1398/01/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Evaluation of the effect of lidocaine-ketorolac mixture and lidocaine on Inferior Alveolar Nerve Block anesthesia in patients with irreversible pulpitis
Public title
Comparison of the Effectiveness of Lidocaine and Lidocaine-Ketoroal Mixture on Mandible Anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients Suffered from Irreversible Pulpitis in Their Lower Mandibular Molars
Patients should be Considered ASA I or II
Exclusion criteria:
Patients who are nursing or lactating during the study
patients suffered from mental or physical disability
patients who are allergic to NSAIDs
patients who are using medicine during the study
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are Selected by Convenience Sampling and Disturbed into Case and Control Group by Random Numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, conventional and changed anesthetic cartridge will be divided and numbered to two groups by an operator.The cartridges will be given to researcher.The researcher who doesn't know type of the cartridges will give them to dentist who wants to do the research.Finally by the permission of patients the research will be done.
Placebo
Not used
Assignment
Single
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
Building No. 4, Isfahan University of Medical Sciences, Hezar Jarib St
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2018-10-24, 1397/08/02
Ethics committee reference number
IR.MUI.RESEARCH.REC.1397.285
Health conditions studied
1
Description of health condition studied
Irreversible Pulpitis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Mandibular Molar Pain
Timepoint
Prior to intervention and After anesthetic injection during root canal treatment
Method of measurement
Heft-Parker's Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After informed contest, the initial anesthetic substance which is lidocaine HCL 2% with epinephrine 1:100,000, will be injected.After that, the studied anesthetic substance (0.8 mL of lidocaine HCL 2% with epinephrine 1:100,000 + 1ml of Ketorolac 30mg/ml) will be injected.Root canal treatment will have started after numbness of lower lip.The patient has been instructed to report the pain on the index if he/she feels any pain.
Category
Treatment - Drugs
2
Description
Control group: On this group, the second injection has normal saline instead of Ketorolac. Other steps are the same as intervention group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental Clinic of Isfahan University of Medical Sciences
Full name of responsible person
Abbasali Khademi
Street address
Isfahan dentistry school, Sofeh St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3673 3513
Email
res@dnt.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo Javanmard
Street address
Isfahan University Of Medical Sciences, Hezarjerib St, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
dnt@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
Hessomoddin Faghihian
Position
Dental Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Isfahan Dentistry School, Sofeh St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 36516128
Email
hesamfgh95@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Reyhaneh Faghihian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Department of Pediatric Dentistry, Isfahan Dentistry School, Sofeh St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3263 8163
Email
r.faghihian@dnt.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hessamoddin Faghihian
Position
Dental Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Isfahan Dentistry School, Sofeh St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3651 6128
Email
hesamfgh95@gmail.com
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Individual patients data after unidentification and the information of the main outcome is available.
When the data will become available and for how long
6 months after the results are published
To whom data/document is available
Researchers working in academic institutions and research centers related to dentistry
Under which criteria data/document could be used
Access to data and documentation is for study purposes only and is not subject to change or analysis
From where data/document is obtainable
Vice-Chancellor's Office for Research, Isfahan Dentistry School
What processes are involved for a request to access data/document
Initially, the relevant scientific evidence and the reasons for the need for data will be provided to the Office of the Vice-Chancellor of Research and after the documents are presented, they will decide.