Efficacy of premedication with Acetaminophen and Ibuprofen on post-operative pain after pulpectomy in primary mandibular molar teeth with irreversible pulpitis
Efficacy of premedication with Acetaminophen and Ibuprofen on postoperative pain after pulpectomy in primary mandibular molar teeth with irreversible pulpitis
Design
Nonrandomized, double-blinded, phase 3 clinical trial with a control group with a group design of 78 patients
Settings and conduct
In this double-blinded study, participants and the Principal Investigator will be kept blind. After preparing the initial graphy with the parallel method, The teeth will be pulpectomized, the roots will be filled with ZOE paste, and then the teeth will be repaired with SSC. A second-year resident will perform the whole treatment process in the pediatric ward of Ahvaz Jundishapur University School of Dentistry. After treatment, the patient's parents will be asked to complete the Wong-baker faces pain rating scale test by asking about the child's pain. Pain intensity will be assessed up to h24 and h48 after treatment.
Participants/Inclusion and exclusion criteria
Entry requirements for participants: History of spontaneous pain; Teeth with internal resorption that involve 1/3 of the root; Teeth with external resorption(not physiological) less than 1/3 of the root length; Conditions for non-entry of participants: Unrestorable crown; Furca radiolucency that involves permanent tooth bud; External resorption more than 1/3 of the root length; Pulp canal obstruction; Existence of systemic disease; two visit pulpectomy
Intervention groups
In the control group, a strawberry-flavored suspension is given to the patient 45 minutes before work.
In the second intervention group, 10-15 mg/kg acetaminophen syrup is given to the patient forty-five minutes before work.
In the third intervention group, ibuprofen suspension 4-10 mg/kg, is given forty-five minutes before work.
Main outcome variables
Measuring the pain after treatment based on Wong-baker faces pain rating scale.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200617047820N1
Registration date:2020-11-16, 1399/08/26
Registration timing:registered_while_recruiting
Last update:2020-11-16, 1399/08/26
Update count:0
Registration date
2020-11-16, 1399/08/26
Registrant information
Name
Bahare Tahmasbi karfi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2207 1959
Email address
tahmasbibahare@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-28, 1399/07/07
Expected recruitment end date
2020-12-27, 1399/10/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of premedication with Acetaminophen and Ibuprofen on post-operative pain after pulpectomy in primary mandibular molar teeth with irreversible pulpitis
Public title
Effect of Acetaminophen and Ibuprofen on post-operative pain after treatment of primary teeth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Teeth that have a history of spontaneous pain
Teeth with internal resorption that involves 1/3 of cervical root.
Teeth with external resorption (not physiological resorption) that involves less than 1/3 of root lenght
Exclusion criteria:
Unrestorable crown
Furcate radiolucency which involves permanent tooth bud
External resorption more than 1/3 of the root length
Pulp canal obstruction
Two visit pulpectomy
Age
From 6 years old to 10 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the principal investigator and the participants will be kept blind, and They do not know which drug the doctor puts in the group. Data collection authorities and those evaluating the outcome and the doctor are aware of the nature of the drug in the relevant group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences
City
َAhvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2020-08-22, 1399/06/01
Ethics committee reference number
IR.AJUMS.REC.1399.419
Health conditions studied
1
Description of health condition studied
Efficacy of premedication with Acetaminophen and Ibuprofen on post-operative pain after pulpectomy in primary mandibular molar teeth with irreversible pulpitis
ICD-10 code
K04.0
ICD-10 code description
Pulpitis
Primary outcomes
1
Description
Pain is measured based on Wong-baker faces pain rating scale.
Timepoint
Measuring the child's pain 24 and 48 hours after treatment
Method of measurement
Wong-baker faces pain rating scale
Secondary outcomes
empty
Intervention groups
1
Description
Control group: They will receive a placebo that contains a strawberry-flavored suspension. The placebo will be given to the patient 45 minutes before work.
Category
Treatment - Drugs
2
Description
Intervention group: In this group, the patient will be given acetaminophen syrup 15-10 mg / kg forty-five minutes before work.
Category
Treatment - Drugs
3
Description
Intervention group: In this group, ibuprofen suspension 4-10 mg / kg will be given to the patient forty-five minutes before work.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Parisa Jafarnejadi
Street address
َAhvaz Jundishapur University of Medical Sciences, Esfand St., Golestan District
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 3817
Email
Info@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
ِDr .Mohammad Badvi
Street address
Ahvaz Jundishapur University of Medical Sciences, Esfand st, Golestan distinct
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 3817
Email
Info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Bahare Tahmasbi Karfi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Unit 6, Besat building, No. 25, Valiasr St., Golestan distinct
City
Ahvaz
Province
Khouzestan
Postal code
6135833376
Phone
+98 912 072 1837
Email
Tahmasbibahare@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Parisa Jafarnejadi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Pediatric Department, Faculty of Dentistry, Ahvaz Jundishapur University of Medical Sciences, Esfand St., Golestan District
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 3817
Email
Jafarnejad.parisa@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Bahare Tahmasbi Karfi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Unit 6 , Besat Building , No. 25 , Valiasr Ave., Golestan District
City
Ahvaz
Province
Khouzestan
Postal code
6135833376
Phone
+98 21 2207 1959
Email
Tahmasbibahare@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available