The effect of ibuprofen premedication on the success of inferior alveolar nerve block anesthesia for primary molars with irreversible pulpitis
Design
Double blinded, controlled, randomized clinical trial, with blinded outcome analysis
Settings and conduct
In this study, patient, physician, the students who introduce pain score sheet to the child and statistician will be blinded to the groups.A total of 42 patients will be randomly divided into two groups. 45 minutes prior to treatment, placebo or ibuprofen will be administered based on the patient's weight (10 mg / kg); then, inferior alveolar nerve block will be performed. 15 minutes after injection, the signs of soft tissue and Lip anesthesia will be examined by a dental explorer. If the patient does not show signs of soft tissue anesthesia,injection will be considered as a failure and the patient will be excluded from the study. The access cavity will then be prepared by dentist and the pain during pulp exposure time will be recorded by the dental assistant. Mild or no pain will be considered as the success of anesthesia and severe or moderate pain will be recorded as a failure.
Participants/Inclusion and exclusion criteria
Inclusion criteria: healthy patients having a carious mandibular primary molar with symptomatic irreversible pulpitis; spontaneous pain of the mentioned tooth; absence of radiolucency in the furcation area.
Exclusion criteria: consumption of NSAIDs or other analgesics in the previous 12 hours; allergy to NSAIDs; history of GI disturbances; presence of necrotic pulp tissue after access cavity preparation
Intervention groups
Prescribing placebo or 100mg/5ml ibuprofen suspension according to patient's weight (10 mg/kg), 30 minutes prior to administration of inferior alveolar nerve block
Main outcome variables
Pain during pulp exposure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161029030552N3
Registration date:2019-03-04, 1397/12/13
Registration timing:retrospective
Last update:2019-03-04, 1397/12/13
Update count:0
Registration date
2019-03-04, 1397/12/13
Registrant information
Name
yasamin khaksar
Name of organization / entity
shiraz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3725 8091
Email address
khaksar_y@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
2017-09-23, 1396/07/01
Actual recruitment end date
2017-11-03, 1396/08/12
Trial completion date
2017-11-03, 1396/08/12
Scientific title
The effect of ibuprofen premedication on the success of inferior alveolar nerve block anesthesia for primary molars with irreversible pulpitis
Public title
The effect of ibuprofen on the pain during pulp therapy of mandibular primary molars
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy patients having a carious mandibular primary molar with symptomatic irreversible pulpitis
Spontaneous pain of the mentioned tooth
Absence of radiolucency in the furcation area
Exclusion criteria:
Consumption of NSAIDs or other analgesics in the previous 12 hours
Allergy to NSAIDs
History of GI disturbances
Presence of necrotic pulp tissue after access cavity preparation
Age
From 6 years old to 10 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
42
Actual sample size reached:
42
Randomization (investigator's opinion)
Randomized
Randomization description
The bottles were numbered by the pharmacist and 42 pockets containing the same number-coded slips of paper, was prepared by a dental aid not associated in the study. In order to allow the patients to be assigned into groups in a random fashion, pockets were introduced to the children and each child received the drug according to the selected pocket.
Blinding (investigator's opinion)
Double blinded
Blinding description
Pharmacist will prepare placebo and ibuprofen with the same flavor and only the pharmacist is aware of the bottles' content. After the completion of treatment, data will be sent to the statistician with the codes of 0 and 1. Therefore, patient, physician, the students who introduce pain score sheet to the child and statistician will be blinded to the groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of ُShiraz University of Medical Sciences
Street address
Central Building of Shiraz University of Medical Sciences, Karim Khan Zand Ave.
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2017-09-23, 1396/07/01
Ethics committee reference number
IR.SUMS.REC.109.1396
Health conditions studied
1
Description of health condition studied
Irreversible pulpitis
ICD-10 code
Pulpitis
ICD-10 code description
K04.0
Primary outcomes
1
Description
Pain
Timepoint
During pulp exposure
Method of measurement
Visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: prescribing Ibuprofen (10 mg/kg) prior to treatment
Category
Prevention
2
Description
Control group: prescribing placebo prior to treatment
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sahami clinic
Full name of responsible person
Dr. Sara Esmaili
Street address
2nd Abiverdi Ave., Chamran Blvd.
City
Shiraz
Province
Fars
Postal code
7195944315
Phone
+98 71 3626 6072
Email
saraesmaili65@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Basir Hashemi
Street address
Shiraz University of Medical Sciences, Zand Ave.
City
Shiraz
Province
Fars
Postal code
7195944315
Phone
+98 71 3212 2389
Email
khaksar_y@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
100
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
Yasamin Khaksar
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shiraz Dental Faculty, Qomabad Ave.
City
Shiraz
Province
Fars
Postal code
7195944315
Phone
+98 71 3626 3193
Email
khaksar_y@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Yasamin Khaksar
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shiraz Dental Faculty, Qomabad Ave.
City
Shiraz
Province
Fars
Postal code
7195944315
Phone
+98 71 3626 3193
Email
khaksar_y@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Yasamin Khaksar
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shiraz dental faculty,Qomabad Ave., Shiraz
City
Shiraz
Province
Fars
Postal code
7195944315
Phone
+98 71 3626 3193
Email
Khaksar_y@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
Demographic data and the result of statistical analysis of the clinical trial
When the data will become available and for how long
Since the publication of the article
To whom data/document is available
Researchers
Under which criteria data/document could be used
After publication of the article
From where data/document is obtainable
Sending email to the researchers
What processes are involved for a request to access data/document