Comparison of Ketorolac and Ketorolac/Acetaminophen on anesthetic efficacy of Inferior Alveolar Nerve Block in patients with asymptomatic irreversible pulpitis
Sixty adult volunteers will randomly divide into three groups (n=20). All patients will receive a capsule including Ketorolak, Ketorolak plus Acetaminophen or placebo 45 minutes before standard infra alveolar nerve block . Endodontic access preparation will initiate after 15 minutes of initial IANB with two negative responses to the electric pulp test. Pain during dentin, access cavity preparation and root canal instrumentation will be recorded using Visual Analog Scale. The success is considered as none or mild pain during treatment. Participants including major eligibility criteria: all patients with asymptomatic irreversible pulpitis (Heft Parker visual analogue scale ≤ 54) of a mandibular molar tooth without systemic diseases; non smoking; without any medicine consumption or analgesic and sedation Intervention: Ketorolac/Ketorolak plus Acetaminophen/Placebo. Main outcome measures : Pain during dentin removal , access cavity preparation and root canal instrumentation using visual analyzing scale
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015081116845N3
Registration date:2015-11-24, 1394/09/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-24, 1394/09/03
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
Islamic Azad University Tehran
Expected recruitment start date
2015-09-11, 1394/06/20
Expected recruitment end date
2016-06-20, 1395/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Ketorolac and Ketorolac/Acetaminophen on anesthetic efficacy of Inferior Alveolar Nerve Block in patients with asymptomatic irreversible pulpitis
Public title
Comparison of two oral analgesic pre-medication on success of intraoral anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
patients with age ranged 18-65; without systemic diseases ; without any medicine consumption; non smoking; non pregnant; non breast feeding; with asymptomatic irreversible pulpitis ( Visual Analog Scale ≤ 54); no allergies and hypersensitivity history to Non-steroidal anti-inflammatory drugs and acetaminophen; need root canal treatment for a mandibular molar
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
ClinicalTrials.gov
Secondary trial Id
NCT02601911
Registration date
1394-08-18, 777/01/-1309
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
19468
Approval date
2015-06-01, 1394/03/11
Ethics committee reference number
ir.iau.ac.ir.1394.166
Health conditions studied
1
Description of health condition studied
Irreversible pulpitis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anesthesia following the injection
Timepoint
5 minutes
Method of measurement
Electric pulp tester
Secondary outcomes
1
Description
Root Canal treatment without pain
Timepoint
15 minutes following injection
Method of measurement
Pain rate based on VAS
Intervention groups
1
Description
10 mg oral Ketorolac
single dose, 45 min. before treatment
Category
Treatment - Drugs
2
Description
10 mg oral Ketorolac plus 1000 mg oral Acetaminophen
single dose, 45 min before treatment
Category
Treatment - Drugs
3
Description
Oral placebo
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Islamic Azad University Tehran Dental Branch
Full name of responsible person
Dr Nahid Mohammadzadeh Akhlaghi
Street address
10th Neyestan, Pasdaran Ave Tehran Tehran
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
Dr Arash Azizi
Street address
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
Islamic Azad University Tehran Dental Branch
Full name of responsible person
Dr Nahid Mohammadzadeh Akhlaghi
Position
Associate Professor /DDS, MS
Other areas of specialty/work
Street address
No 4, 10t Neyestan, Pasdaran Ave.
City
Tehran
Postal code
19468
Phone
+98 21 2201 1751
Fax
Email
akhlaghinahid@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University Tehran Dental Branch
Full name of responsible person
Dr 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
19468
Phone
+98 21 2201 1751
Fax
Email
akhlaghinahid@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University Tehran Dental Branch
Full name of responsible person
Dr 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
19468
Phone
+98 21 2201 1751
Fax
Email
akhlaghinahid@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)