Objective: The aim of this study is to evaluate premedication with ketorolac infiltration on post endodontic pain in patients with symptomatic irreversible pulpitis. Design: Randomized double blind clinical trial Setting and conduct: Sixty adult volunteers with including criteria will be divided into two groups (n=30) based on random table. All patients will receive standard inferior alveolar nerve block of 2% lidocaine with 1:800000 epinephrine and supplemental buccal infiltration of 0.9 mL 2% lidocaine with 1:800000 epinephrine. After five minutes one group will receive supplemental buccal infiltration of 30 mg/mL of Ketorolac Tromethamine and the control group will receive buccal infiltration of normal saline. Endodontic access preparation will initiate after 15 minutes of initial IANB with two negative responses to the electric pulp test. Endodontic treatment of all the patients will be performed in a single visit, using crown down method and with rotary instrumentation till master apical file size# 30.06. The pain level will be immediately recorded after the treatment and at the 2,4,6 and 24 hours following the Ketorolac infiltration using Heft- Parker Visual Analog Scale (HP- VAS). Data will be evaluated using Repeated measured test (if possible) and otherwise non-parametric tests such as rival Friedman and X2 test. SPSS version 22 will be used for data analysis .Participants including major eligibility criteria: all patients age ranged 18-65 with symptomatic irreversible pulpitis (HP VAS ≥54) of a mandibular molar tooth who need root canal treatment and are without systemic diseases; nonsmoking;non pregnant, non breat feeding without any medicine consumption or analgesic and sedation Intervention: Ketorolac infiltration Main outcome measures : Pain level at immediately after the treatment, 2,4,6 and 24 hours following the root canal treatment using HP VAS.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016061316845N6
Registration date:2016-09-25, 1395/07/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-09-25, 1395/07/04
Registrant information
Name
Nahid Akhlaghi
Name of organization / entity
Tehran Dental Branch Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 21 2201 1751
Email address
n_akhlaghi@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor of Research ,Dental Branch Tehran Islamic Azad University
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-01-19, 1395/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Premedication effect of Ketorolac infiltration injection on post endodontic pain
Public title
Premedication effect of an anti inflammatory analgesic on post root canal treatment pain
Purpose
Prevention
Inclusion/Exclusion criteria
patients with age ranged 18-65; without systemic diseases ; without any medicine consumption; nonsmoking; non pregnant; non breast feeding; with symptomatic irreversible pulpitis ( Visual Analog Scale ≥ 54) in one mandibular molar who need root canal therapy
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University, Tehran dental Branch
Street address
10th Neyestan, Pasdaran Ave
City
Tehran
Postal code
18468
Approval date
2016-06-20, 1395/03/31
Ethics committee reference number
ir.iau.rec.1395.190
Health conditions studied
1
Description of health condition studied
Post endodontic Pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain after root canal treatment
Timepoint
Immediately after the treatment and at the 2,4,6 and 24 hour intervals
Method of measurement
Pain rate based on analgesic demand and VAS
Secondary outcomes
empty
Intervention groups
1
Description
Injection of Ketorolac infiltration
Category
Treatment - Drugs
2
Description
Injection of normal saline infiltration
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Post grad Endodontic Department, Dental Branch, Tehran Islamic Azad University
Full name of responsible person
Mahsa Azarshab
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor of Research ,Dental Branch Islamic Azad University
Full name of responsible person
Arash azizi
Street address
no 4, 10th Neyestan, Pasdaran Ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of Research ,Dental Branch Islamic Azad University
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
Dental Branch, Tehran Islamic azad University
Full name of responsible person
Nahid Mohammadzadeh Akhlaghi
Position
Associate Professor /DDS, MS
Other areas of specialty/work
Street address
No 4,10th Neyestan, Pasdaran Ave
City
Tehran
Postal code
Phone
+98 21 2201 1751
Fax
Email
akhlaghinahid@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental Branch, Tehran Islamic Azad University
Full name of responsible person
Nahid Mohammadzadeh Akhlaghi
Position
Associate Professor /DDS, MS
Other areas of specialty/work
Street address
No 4,10th Neyestan, Pasdaran Ave
City
Tehran
Postal code
Phone
+98 21 2201 1751
Fax
Email
akhlaghinahid@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dental Branch, Islamic Azad University
Full name of responsible person
Nahid Mohammadzadeh Akhlaghi
Position
Associate Professor/DDS, MS
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)