Objectives: This study aimed to evaluate the efficacy premedication of two analgesics on success of intra oral injection. Design: Sixty adult volunteers who refer to Endodontic department, Tehran Islamic Azad University, will randomly divide into three groups (n=20) in this prospective randomized triple-blind clinical trial. Conduct and setting: All the 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 after root canal treatment will be recorded using Heft Parker Visual Analog Scale(VAS). The success is considered as none or mild pain after treatment. Intervention: Ketorolac/Ketorolak plus Acetaminophen/Placebo. Main outcome measures : Pain after root canal treatment during 6,12,24 and 48 hour intervals using VAS.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015102916845N4
Registration date:2015-12-12, 1394/09/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-12-12, 1394/09/21
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
Premedication efficacy of oral Ketorolac and Ketorolac/ Acetaminophen on post endodontic treatment pain
Public title
Premedication efficacy of two oral analgesic on post root canal treatment pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion 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(VAS) ≤ 54); no allergies and hypersensitivity history to non-steroidal anti-inflammatory drugs and acetaminophen; need root canal treatment for a mandibular molar
Exclusion criteria: patients younger than 18 and older than 65; systemic diseases; any medicine consumption; pregnant and breast feeding;VAS more than 54; allergic history to drugs; normal pulp; no need to root canal treatment
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
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; with understanding, accepting and signing the consent and VAS forms.
Questionnaire and consent forms are blindly placed and blocked in a sealed envelope using random table.
Secondary Ids
1
Registry name
ClinicalTrials.gov
Secondary trial Id
NCT02614118
Registration date
2015-11-23, 1394/09/02
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University, Tehran dental Branch
Street address
No 4,10th Neyestan, Pasdaran Ave
City
Tehran
Postal code
Approval date
2015-05-05, 1394/02/15
Ethics committee reference number
ir.iau.rec.1394.139
Health conditions studied
1
Description of health condition studied
Irreversible pulpitis
ICD-10 code
Z40-Z54
ICD-10 code description
این بیماران جهت انجام درمان ریشه دندانها بدون علایم درد مراجعه مینمایند
Primary outcomes
1
Description
Pain after root canal treatment
Timepoint
6,12,24 and 48 hour intervals
Method of measurement
Pain rate based on VAS
Secondary outcomes
empty
Intervention groups
1
Description
10 mg oral Ketorolac( Iran Hurmon Co. Tehran, Iran), single dose, 45 min. before treatment
Category
Treatment - Drugs
2
Description
10 mg oral Ketorolac plus 1000 mg oral Acetaminophen( Arya Pharmaceutical Co. Tehran, Iran), single dose, 45 min before treatment
Category
Treatment - Drugs
3
Description
Oral placebo, single dose 45 minutes befor treatment
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
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Dental Branch, Tehran Azad University of Medical Sciences
Full name of responsible person
Nahid mohammadzadeh Akhlaghi
Street address
No4, 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 for research of Dental Branch, Tehran Azad University of Medical Sciences
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. Tehran
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
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
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
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
Phone
+98 21 2201 1751
Fax
Email
akhlaghinahid@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)