Hemodynamic changes after administration of 2% lidocaine with 1:100,000 epinephrine compared to 4% articaine with 1:100,000 epinephrine: prospective, double-blinded, randomized clinical trial
To compare hemodynamic changes after administration of 2% lidocaine with 1:100,000 epinephrine and 4% articaine with 1:100,000 epinephrine
Design
A prospective, parallel-group, double-blinded, randomized controlled trial
Settings and conduct
Patients who required surgical extraction of wisdom teeth were randomly allocated to 2 intervention groups. patient and surgeon were blinded to the intervention and investigator collected data according to the number of an envelope containing intervention.
Participants/Inclusion and exclusion criteria
Healthy patients with blood pressure below 140/90
Intervention groups
patients who received 4% articaine with 1:100,000 epinephrine
Main outcome variables
hemodynamic change
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180330039161N2
Registration date:2019-08-04, 1398/05/13
Registration timing:prospective
Last update:2019-08-04, 1398/05/13
Update count:0
Registration date
2019-08-04, 1398/05/13
Registrant information
Name
Saeid Tavanafar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3230 6655
Email address
Tavanafar@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-12, 1398/06/21
Expected recruitment end date
2020-01-20, 1398/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Hemodynamic changes after administration of 2% lidocaine with 1:100,000 epinephrine compared to 4% articaine with 1:100,000 epinephrine: prospective, double-blinded, randomized clinical trial
Public title
Hemodynamic effects of 2% lidocaine with 1:100,000 epinephrine compared to 4% articaine with 1:100,000 epinephrine
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
ASA 1 and 2
Level A and Class I Pell and Gregory classification of impacted mandibular third molars
patients who weren’t diagnosed as hypertensive and their blood pressure <140/90 mm Hg
Exclusion criteria:
hypertension
cardiovascular disease
sickle cell anemia
congenital methemoglobinemia
pregnancy
hyperthyroidism
breastfeeding
allergy to local anesthetics
any contraindications to epinephrine
if the extraction required more than 2 local anesthetic cartridges
the duration exceeded 45 minutes
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The simple method of randomization sequentially numbered, opaque, sealed envelopes with random sequence in a way that surgeon and patients would be blinded of the anesthetic used
Blinding (investigator's opinion)
Double blinded
Blinding description
Participant and surgeon were blinded by sequentially numbered, opaque, sealed envelopes containing either of the 2 interventions. Investigator then used the data for statical analysis using the numbered envelope which was associated with each intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
No 2, felestin Ave, Zand Boulevard
City
Shiraz
Province
Fars
Postal code
7134647637
Approval date
2019-06-09, 1398/03/19
Ethics committee reference number
IR.SUMS.REC.1398.516
Health conditions studied
1
Description of health condition studied
Impacted mandibular third molar
ICD-10 code
T49.7X6A
ICD-10 code description
Underdosing of dental drugs, topically applied, initial encounter
Primary outcomes
1
Description
Hemodynamic change
Timepoint
Before surgery, after anesthetic injection, after surgical removal of the impacted third molars
Method of measurement
pulse oximetry, electronic sphygmomanometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients candidate of surgical removal of mandibular third molar removal received two capules of 1.8 mg of 4% articaine with 1:100,000 epinephrine to anesthetize the surgical site.
Category
Treatment - Drugs
2
Description
Control group: Patients in control group recieved the routine anesthetic solution of two carpules of 1.8mg of 2% lidocaine with 1:100,000 epinephrine.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry, Shiraz University of Medical Sciences
Full name of responsible person
Saeid Tavanafar
Street address
No. 2, felestin street, Zand boulevard
City
Shiraz
Province
Fars
Postal code
7134647637
Phone
+98 71 3230 6655
Email
tavanafar@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Samira Karanjam
Street address
No 2, felestin street, Zand boulvard
City
Shiraz
Province
Fars
Postal code
7134647637
Phone
+98 71 3230 6655
Email
tavanafar@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
10
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
Shiraz University of Medical Sciences
Full name of responsible person
Saeid Tavanafar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No 2, felestin street, Zand Boulevard
City
Shiraz
Province
Fars
Postal code
7134647637
Phone
+98 71 3230 6655
Email
tavanafar@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Saeid Tavanafar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No 2, felestin street, zand boulevard
City
Shiraz
Province
Fars
Postal code
7134647637
Phone
+98 71 3230 6655
Email
tavanafar@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Saeid Tavanafar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No 2, felestin street, Zand boulevard
City
Shiraz
Province
Fars
Postal code
7134647637
Phone
+98 71 3230 6655
Email
tavanafar@sums.ac.ir
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
Part of data related to variables will be shared
When the data will become available and for how long
starting in January 2020
To whom data/document is available
Academic institutions
Under which criteria data/document could be used
Be part of an academic institution
From where data/document is obtainable
Contact Saeid Tavanafar by Email: s.tavanafar@gmail.com
What processes are involved for a request to access data/document