Comparing the analgesic effect of single-dose preoperative administration of noblegin, celecoxib and advalgin ER on demand for next dose of analgesic in mandibular third molar surgery
Comparing the analgesic effect of preoperative administration of noblegin,celecoxib & advalgin ER on demand for postoperative analgesic use in mandibular third molar surgery
Design
A triple blind,parallel group& placebo control clinical trial study on 120 healthy patients aged 15 to 29 years.A dose of the study drugs & placebo is given to the patient 30 minutes pre surgery.Iboprufen 400 mg is prescribed as a rescue drug for all groups.It is recommended that patients use painkillers if they experience moderate to severe pain(VAS≥4).Random allocation 0.2 software will be used for randomization.
Settings and conduct
In the Tuba Sari Dental Clinic,surgerys will be performed on healthy patients candidated for wisdom tooth surgery aged 15 to 29 years old. The patient, the surgeon and the analyst will be unaware of the type of analgesic (triple blinded).
Participants/Inclusion and exclusion criteria
Inclusion criteria:ASA class I patients Candidated for prophylactic removal of mandibular third molar,full or partial bony impaction confirmed by panoramic X-ray;
Requiring soft tissue flap,bone manipulation & bone removal.
Non inclusion criteria:Smokers;
Pregnant or breastfeeding women or women of child bearing potential not using adequate contraception;
Allergy or hypersensitivity to study or rescue medication or any other nsaids,opioids and acetyl salicylic acid;
History of NSAID-sensitive asthma.
Intervention groups
Intervention group1:a pre-operative dose of 330 mg Nobelgin tablets
Intervention group2:a pre-operative dose of 600 mg Advalgin ER coated tablet
Intervention group3:a pre-operative dose of 200 mg celecoxib capsules
Control group:a pre-operative dose of placebo
Main outcome variables
The number of patients needing analgesics; the time of the first analgesic consumption; the total number of analgesic use; the post surgery pain level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221207056746N1
Registration date:2023-05-31, 1402/03/10
Registration timing:registered_while_recruiting
Last update:2023-05-31, 1402/03/10
Update count:0
Registration date
2023-05-31, 1402/03/10
Registrant information
Name
zohre mozoun
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3335 6194
Email address
yasaman.mozoun@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-02, 1401/08/11
Expected recruitment end date
2023-08-01, 1402/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the analgesic effect of single-dose preoperative administration of noblegin, celecoxib and advalgin ER on demand for next dose of analgesic in mandibular third molar surgery
Public title
Comparison of the analgesic effect of three analgesics before surgery in pain after mandibular wisdom tooth surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy patients (ASA class I)
Candidates of prophylactic removal of mandibular third molar,full or partial bony impaction confirmed by panoramic X-ray
Requiring soft tissue flap, bone manipulation and bone removal
No medication consumption in the past 21 days
The presence of the first and second molars
Good oral hygiene
Absence of pericoronitis or inflammation signs
Absence of local or systemic infection
Exclusion criteria:
Smokers
Pregnant or breastfeeding women or women of child bearing potential not using adequate contraception
Allergy or hypersensitivity to study treatments, rescue medication (rm) or any other nsaids, opioids and acetyl salicylic acid
History of NSAID-sensitive asthma
History of or the suspicion of drug or alcohol abuse
Apical radiolucent image in target tooth
Consmuption of central nervous system depressants
Pre-existing pain and acute inflammation
Inability to understand or perform the study procedure
Psychosis
Consumption of caffeine-containing beverages, chocolate, or alcohol within 4 hours prior to surgery
Oral contraception use
Being in the menstrual period
Any contraindication of cox-2 inhibitors use
Age
From 15 years old to 29 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization (blocks of size 4); Individual.
Randomization tool: random allocation software 2;
How to make a random sequence and how to hide it: Using the software, codes A and B will be generated, where code A means applying the intervention group and code B means applying the control group for each person. Finally, the codes will be placed in the sealed envelope and the number of each patient will be written on the envelope. As each patient enters, the doctor will open the envelope and apply the desired treatment
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patients, surgeon, data collector and biometrician will be unaware of the analgesic treatment (triple blind design). Medications and palcebo will be given to patients in dark matte jars of one color by the assistant before surgery so only the assistant is aware of the type of medicine.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Third floor; Mozoun 20 building, Bustan1, Pasdar alley,Imam square
City
Sari
Province
Mazandaran
Postal code
4815837614
Approval date
2022-12-24, 1401/10/03
Ethics committee reference number
IR.MAZUMS.REC.1401.430
Health conditions studied
1
Description of health condition studied
postoperative pain
ICD-10 code
G89
ICD-10 code description
Pain, not elsewhere classified
Primary outcomes
1
Description
postoperative pain intensity
Timepoint
4hours & 7 hours postsurgery,the first day and the third day after surgery
Method of measurement
Visual Analogue Scale
2
Description
the time of first analgesic intake
Timepoint
one week after surgery
Method of measurement
Referring to document
3
Description
The number of patients who needed analgesics (vas≥4)
Timepoint
One week after surgery
Method of measurement
Referring to patients' documents
4
Description
the total number of analgesics used
Timepoint
One week after surgery
Method of measurement
Referring to patients' documents
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: pre-operative consumption of one Nobelgin tablet manufactured by Pars Daru Pharmaceuticals, each tablet contains acetaminophen 300 mg, caffeine 15 mg and codeine 15 mg
Category
Treatment - Drugs
2
Description
Intervention group 2: pre-operative consumption of a 600 mg Advalgin AR coated tablet containing 200 mg ibuprofen in quick-release form and 400 mg in extended release form, manufactured by Abidi Pharmaceuticals
Category
Treatment - Drugs
3
Description
Intervention group 3: pre-operative consumption of one 200 mg celecoxib capsule, manufactured by Elixir Pharmaceuticals
Category
Treatment - Drugs
4
Description
Control group: pre-operative consumption of one placebo tablet (starch)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sari Tuba dentistry clinic
Full name of responsible person
Amirhossein Moaddabi
Street address
Khazar square
City
Sari
Province
Mazandaran
Postal code
4815837614
Phone
+98 11 3335 6194
Email
yasaman.mozoun@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
amirhossein moaddabi
Street address
Sari Dental school,next to Tubi Clinic,Khazar Blvd,Sari
City
sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3325 4135
Email
yasaman.mozoun@gmail.com
Web page address
https://mazums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
superviser & sari dental school
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
Mazandaran University of Medical Sciences
Full name of responsible person
Amirhossein Moaddabi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Sari Dental school, next to Tubi Clinic, Khazar Blvd, Sari
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3335 6194
Email
A.moaddabi2@gmail.com
Web page address
https://mazums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Amirhossein Moaddabi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Sari Dental school, next to Tubi Clinic, Khazar Blvd, Sari
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3335 6194
Email
A.moaddabi2@gmail.com
Web page address
https://mazums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Zohreh Mozoun
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Dentistry
Street address
Third floor; Mozoun 20 building, Bustan1, Pasdar alley,Imam square
City
sari
Province
Mazandaran
Postal code
4815837614
Phone
+98 11 3335 6194
Email
yasaman.mozoun@gmail.com
Web page address
https://mazums.ac.ir/
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
Yes - There is 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
Title and more details about the data/document
it is not planned yet
When the data will become available and for how long
it is not planned yet
To whom data/document is available
it is not planned yet
Under which criteria data/document could be used
it is not planned yet
From where data/document is obtainable
it is not planned yet
What processes are involved for a request to access data/document