Comparison of the Effects Pre treatment with Acetaminophen and Ibuprofen in Inferior Alveolar Nerve Block of Second Primary Molar Teeth with Irreversible Pulpitis
The aim of present study is to compare the effects of pretreatment Acetaminophen and Ibuprofen in inferior Alveolar nerve block in the second primary molar teeth with Irreversible pulpitis.
The present study was conducted in a double-blind and randomized manner. The subjects (n=30) were selected in three groups (n=10) from patients referring to the Department of Pediatrics, Tabriz Faculty of Dentistry. Inclusion criteria: children with no history of allergy to Acetaminophen and Ibuprofen; allergy to 2% Lidocaine Anesthetic drugs with 1/200000 epinephrine; no record of intraoral injection; having no unpleasant experience of medical record; phobia from dentistry and no use of analgesic agents during the previous 24 hours periods; mandibular second primary molar with irreversible pulpits without alveolar abscess.
Exclusion criteria: systemic diseases; allergy to lidocaine with 1/200000 epinephrine; allergy to anti-inflammatory nonsteroidal drugs peptic ulcer and use of any pain- killer 24 hours before treatment. Before Local anesthesia, group 1 received 15 mg/kg of Acetaminophen pretreatment in suspension form and group 2 received 5 mg/kg of Ibuprofen pretreatment in syrup form in the same method. Placebo was used in group 3, which was theis control group. The patients’ pain was measured using visual analogue scale, 5 minutes after injection of the anesthetic agent.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016083129618N2
Registration date:2016-09-05, 1395/06/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-09-05, 1395/06/15
Registrant information
Name
Shukufe Najafi Dehkordi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 5965
Email address
shukuh.najafi89@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Tabriz University of Medical Sciences
Expected recruitment start date
2016-08-23, 1395/06/02
Expected recruitment end date
2016-08-28, 1395/06/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effects Pre treatment with Acetaminophen and Ibuprofen in Inferior Alveolar Nerve Block of Second Primary Molar Teeth with Irreversible Pulpitis
Public title
Comparison of the Effects Pre treatment with Acetaminophen and Ibuprofen in Success of Anesthesia in the Lower Jaw with Infected Second Primary Molar Teeth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: children with no history of allergy to Acetaminophen and Ibuprofen; allergy to 2% Lidocaine Anesthetic drugs with 1/200000 epinephrine; no record of intraoral injection; having no unpleasant experience of medical record; phobia from dentistry and no use of analgesic agents during the previous 24 hours periods; mandibular second primary molar with irreversible pulpits without alveolar abscess.
Exclusion criteria: systemic diseases; allergy to lidocaine with 1/200000 epinephrine; allergy to anti-inflammatory nonsteroidal drugs peptic ulcer and use of any pain- killer 24 hours before treatment.
Age
From 6 years old to 8 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
All drugs were selected from the same pharmaceutical company, packed in similar bottles in the Faculty of Pharmacology of Tabriz and then packed in uniform bottles by a third person, classified in three groups of A, B and C. All the packs were labeled and coded randomly and each patient will receive a pack before injection . The randomized codes were hidden from the researchers, nurses and the patients and will be kept in a safe place until the end of the study ( The drug bottles were prepared considering patients weights ).
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Ethics Committee of Tabriz University of Medical Sciences,Vice Chancellor for Research of Tabriz University of Medical Sciences,Tabriz University of Medical Sciences, Golgasht street, Tabriz
City
Tabriz
Postal code
118-51665
Approval date
2016-08-23, 1395/06/02
Ethics committee reference number
IR.TBZMED.REC.1395.495
Health conditions studied
1
Description of health condition studied
Irreversible pulpitis
ICD-10 code
K04.0
ICD-10 code description
Pulpitis
Primary outcomes
1
Description
Pain Relief after Local Anestasia Injection
Timepoint
5 minute after Local Anestasia Injection
Method of measurement
VAS( Visual Analgesic Scale)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1:1 hour Befor Local anesthesia, used 15 mg/kg of Acetaminophen pretreatment.
Category
Treatment - Drugs
2
Description
Intervention group2:1 hour Before Local anesthesia, used 5 mg/kg of Ibuprofen pretreatment
Category
Treatment - Drugs
3
Description
Control group: 1 hour before Local anesthesia used placebo.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Pediatric, Dental Faculty of Tabriz University of Medical Sciences
Full name of responsible person
Hamed Abadi
Street address
Department of pediatric , Tabriz Dental Faculty, Tabriz University of Medical Sciences
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Reza Rashidi
Street address
Vice Chancellor for Research, Tabriz University of Medical Sciences, Golgasht street
City
Tabriz
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, Tabriz 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
Department of Pediatric, Dental Faculty of Tabriz University of Medical Sciences
Full name of responsible person
Hamed Abadi
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Pediatric, Tabriz Dental Faculty, Tabriz University of Medical Sciences,Golgasht
City
Tabriz
Postal code
5166614713
Phone
+98 41 3329 4312
Fax
Email
Hamed.abadi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Pediatric, Dental Faculty of Tabriz University of Medical Sciences
Full name of responsible person
Hamed Abadi
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of pediatric , Tabriz Dental Faculty, Tabriz University of Medical Sciences,Golgasht St
City
Tabriz
Postal code
5166614713
Phone
+98 41 3329 4312
Fax
Email
Hamed.abadi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of pediatric, Dental Faculty of Tabriz University of Medical Sciences
Full name of responsible person
Hamed Abadi
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Pediatric , Tabriz Dental Faculty, Tabriz University of Medical Sciences,Golgasht St
City
Tabriz
Postal code
5166614713
Phone
+98 41 3329 4312
Fax
Email
Hamed.abadi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)