Comparison of preemptive analgesic effect of Naproxen, Celecoxib and Acetaminophen codeine on pain control after mandibular third molar surgery in patients to dentistry clinic of bushehr university of medical sciences
The purpose of this study was to compare the analgesia effect of naproxen, celecoxib and acetaminophen codeine on pain control after third molar extraction of mandibular molars and the feasibility of replacement of non-steroidal anti-inflammatory drugs, an inhibitor of COX-2.
Design
This study was a blind, parallel, randomized, and controlled double-blind clinical trial in 72 patients referred to the dental clinic of Bushehr University of Medical Sciences. Patients were randomly divided into 3 groups, each group received 250 mg naproxen, 100 mg of celecoxib and 325 mg of acetaminophen codeine for half an hour before surgery.
Settings and conduct
The location of the study was a dental clinic at Bushehr University. The drugs were insulated into light and temperature insulated glasses and encoded under sterile gamma-ray lab conditions and were not known to Surrey, neither patients nor surgeons of the type of medication. Delivery of the drug to the patient and follow up of the patient's condition by someone other than the surgeon. The drug was used on the label of the drug.
Participants/Inclusion and exclusion criteria
A graph to confirm that the third molar is the same, the pain rating on the patient - the patient does not have a history of systemic diseases - the patient does not have a history of allergic to steroid drug - Avoid at least 48 hours before taking an analgesic drug - The patient is able to read and understand the checklist.
Intervention groups
A total of 72 patients aged 18-40 years old referred to the dental clinic of Bushehr University of Medical Sciences in 1998-97 were evaluated to compare the analgesic effects of celecoxib, naproxen and acetaminophen codeine.
Main outcome variables
Record the pain, the time and the total number of consumable painkillers
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190615043899N1
Registration date:2019-07-16, 1398/04/25
Registration timing:retrospective
Last update:2019-07-16, 1398/04/25
Update count:0
Registration date
2019-07-16, 1398/04/25
Registrant information
Name
Seyed mehdi Hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77 3344 8061
Email address
pmn.hsn30067@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-05-31, 1398/03/10
Actual recruitment start date
2019-02-20, 1397/12/01
Actual recruitment end date
2019-05-16, 1398/02/26
Trial completion date
2019-05-16, 1398/02/26
Scientific title
Comparison of preemptive analgesic effect of Naproxen, Celecoxib and Acetaminophen codeine on pain control after mandibular third molar surgery in patients to dentistry clinic of bushehr university of medical sciences
Public title
Comparison of preemptive analgesic effect of Naproxen, Celecoxib and Acetaminophen codeine on pain control after mandibular third molar surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient OPG to confirm that the hardness of the lower third molar is the same.
Patient-patient pain rating
History of systemic diseases
Patient should not have a history of hypersensitivity to steroid drugs
Patient in the range of 18 to 60 years old
Avoid taking an hour before taking analgesic
A person can read and understand the checklist
The patient does not take analgesic because of chronic pain
Exclusion criteria:
There is an infection of the postoperative dry socket
Diabetic patients
Systemic drug interactions with the three drugs in this study
Use of psychological drugs
The presence of rotting teeth or needing treatment in the mouth
Lack of cooperation for future referrals
Systemic disease
People who had started treating the wound of the gastrointestinal tract for 30 days before surgery
Used analgesics or another drug for 24 hours before surgery
History of narcotic or analgesic addiction
Patients who were pregnant or Breastfeeding
Known sensitivity to anti-inflammatory drugs, non-steroidal anti-inflammatory drugs ordinary or cyclooxygenase-2 inhibitors
Age
From 18 years old to 40 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
78
Actual sample size reached:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into three groups of 24 patients using randomized block method. According to random block allocation method, first, the volume of each block is determined, in this study, 12 blocks of 6 blocks were determined. After the block list was prepared, a number was allocated to each block. Then, random numbers were chosen between 1 and 12, and the random allocation list was selected according to the order of random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
The way of blinding was this: the drugs were embedded in insulating glasses of light and temperature and encoded under sterile gamma rays under laboratory conditions. The sample code was revealed after the study was completed and the results were revealed. Delivery of the drug to the patient and follow up of the patient's condition by someone other than the surgeon. The method of administration of the drug on the label of the drug was determined to be patient; who took the drug for three days according to the instructions, ie, naproxen 250 mg every 6 hours, celecoxib 100 mg every 12 hours and acetaminophen 325 mg every 6 hours.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Bushehr University of Medical Sciences
Street address
No. 1, Line 332, Deadlock 4, Imam Blvd
City
Bushehr
Province
Boushehr
Postal code
75167-96479
Approval date
2019-02-18, 1397/11/29
Ethics committee reference number
IR.BPUMS.REC.1397.113
Health conditions studied
1
Description of health condition studied
Control of pain after third molar surgery
ICD-10 code
XIX
ICD-10 code description
Injury, poisoning and certain other consequences of external causes
Primary outcomes
1
Description
The severity of pain
Timepoint
The severity of pain was the patient who was recorded in the questionnaire during the prescribed hours (7 days and 72, 48, 24, 12, 8, 4)
Method of measurement
The severity of pain was as follows: the patient, based on her sense of pain, determined a number between 10-1 according to the definition of the pain states based on the degree of discomfort / pain. The number 1 indicates that the patient feels good and does not feel pain, and the number 10 indicates a painful pain, to the extent that the patient leaves all his work and feels the need for rest.
Secondary outcomes
empty
Intervention groups
1
Description
Control group: In this study, acetaminophen codein was used as a standard dose (control) to evaluate the efficacy of other drugs; So, half an hour before, surgery was given to a group of acetaminophen 325 mg.
Category
Treatment - Drugs
2
Description
Intervention group: Half an hour before surgery, naproxen 250 mg (Pars Dara Company) was givenby this group.
Category
Treatment - Drugs
3
Description
Intervention group: Half an hour before surgery, another group took100 mg celecoxib (Darupakhsh, Tehran).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental Clinic of Bushehr University of Medical Sciences
Full name of responsible person
Seyed Mehdi Hosseini
Street address
Bushehr University of Medical Sciences, Dental Clinic, Shahid Heidari St
City
Bushehr
Province
Boushehr
Postal code
75167-96479
Phone
+98 77 3344 8061
Email
pmn.hsn30067@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Mehnush khakzad
Street address
Bushehr University of Medical Sciences,Teacher's Street
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3345 0178
Email
M.Khakzad@Bpums.Ac.Ir
Grant name
Deputy of Research of Bushehr University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Boushehr 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
Boushehr University of Medical Sciences
Full name of responsible person
Seyed Mehdi Hosseini
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 1, Line 332, Deadlock 4, Imam Blvd
City
Bushehr
Province
Boushehr
Postal code
75167-96479
Phone
+98 77 3344 8061
Email
pmn.hsn30067@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Seyed Mehdi Hosseini
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 1, Line 332, Deadlock 4, Imam Blvd
City
Bushehr
Province
Boushehr
Postal code
75167-96479
Phone
+7 733448061
Email
pmn.hsn30067@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Seyed Mehdi Hosseini
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 1, Line 332, Deadlock 4, Imam Blvd
City
Bushehr
Province
Boushehr
Postal code
75167-96479
Phone
+98 77 3344 8061
Email
pmn.hsn30067@gmail.com
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
Only part of the data, such as the key outcome information or the like, can share
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
Not allowed
From where data/document is obtainable
Dr seyed mehdi hosseini
pmn.hsn30067@gmail.com
What processes are involved for a request to access data/document