Evaluation of pain after mandibular impacted third molar surgery following pregabalin and acetaminophen
Design
A clinical trial with the parallel intervention group, double blind, randomized on 32 patients. The sampling method is random. The randomization method is simple and with a table of random numbers.
Settings and conduct
Among the patients referred to the Department of Oral and Maxillofacial Surgery of Tabriz Faculty of Dentistry, who are present for the surgery of bilateral mandibular impacted third molar teeth, participate in the study. Patients are randomly assigned to one of the groups. The first group received acetaminophen 650 mg and the second group received pregabalin 150 mg with 100 cc of water. The surgery is performed on the right tooth. One month after the first surgery, the drugs will be changed and the opposite tooth surgery will be performed in the same way by the same surgeon. Patients will record their post-surgery pain level every two hours for 24 hours based on VAS in the prescribed table. The evaluator and the patient are not aware of the type of drug used.
Participants/Inclusion and exclusion criteria
Include criteria: Candidates for surgery on the third molar of the mandible on both sides that are of the same level of difficulty.
Exclude criteria: History of chronic use of pregabalin, history of pain in the mandibular molar region
Intervention groups
Intervention: use of pregabalin 150 mg one hour before surgery
Control: use of acetaminophen 650 mg one hour before surgery
Main outcome variables
The amount of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220316054314N1
Registration date:2022-07-08, 1401/04/17
Registration timing:registered_while_recruiting
Last update:2022-07-08, 1401/04/17
Update count:0
Registration date
2022-07-08, 1401/04/17
Registrant information
Name
Amir Alizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3656 9686
Email address
amir1994alizade@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-04, 1401/04/13
Expected recruitment end date
2022-07-30, 1401/05/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of pain after mandibular impacted third molar surgery following pregabalin and acetaminophen
Public title
Investigation of pain after implanted tooth surgery following taking pregabalin and acetaminophen
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients 18-35 years old
Candidate for surgery on the hidden third molar of the lower jaw on both sides
Exclusion criteria:
History of diabetes controlled by oral medications
Using Corticosteroid
History of using drug
History of using chronic NSAID drugs
History of chronic use of pregabalin or sedative drugs
History of painkiller consumption in the last 24 hours
Psychiatric disorder
History of bone disease
History of bilateral mandibular molar pain
Age
From 18 years old to 35 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
32
More than 1 sample in each individual
Number of samples in each individual:
2
Patients on both sides need mandibular third molar surgery.
Randomization (investigator's opinion)
Randomized
Randomization description
The method of random sampling is among the people who refer to the maxillofacial surgery department of Faculty of Dentistry in Tabriz. The randomization method is simple and individual. Our tool for randomizing a table of random numbers. Also, the allocation of treatment to patients will be done randomly. In such a way that the type of treatment is specified with the code A (acetaminophen) and B (pregabalin) and will be placed inside the sealed envelopes; Then the envelopes will be placed in a bag and mixed. Then it will be randomly removed from the bag and after seeing the code, the treatment will be given to the patient. None of the patients will be informed about the type of treatment of another patient.
Blinding (investigator's opinion)
Double blinded
Blinding description
Medicines will be coded in similar containers with A and B codes. The evaluator who will follow the patients and record their pain level and painkillers will not be aware of the type of drugs. Also, the patient is aware of the existence of two types of drugs, but they will not be aware of the type of drug in each surgery.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
2nd Floor, Central Building No. 2,Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2022-06-27, 1401/04/06
Ethics committee reference number
IR.TBZMED.REC.1401.290
Health conditions studied
1
Description of health condition studied
Impacted teeth
ICD-10 code
K01.1
ICD-10 code description
Impacted teeth
Primary outcomes
1
Description
The amount of pain
Timepoint
Up to 24 hours after surgery, once every two hours
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 150 mg of pregabalin with 100 cc of water will be given to the patient one hour before the mandibular third molar extraction surgery. Up to 24 hours after surgery, the patient will record the level of pain every two hours based on the VAS on the designated table.
Category
Treatment - Drugs
2
Description
Control group: 650 mg of acetaminophen with 100 cc of water will be given to the patient one hour before the mandibular third molar extraction surgery. Up to 24 hours after surgery, the patient will record the level of pain every two hours based on the VAS on the designated table.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry, Tabriz
Full name of responsible person
Farrokh Farhadi
Street address
Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 6058 3553
Email
farhadif@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mozhgan Kechoui
Street address
Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 6058 3553
Email
farhadif@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Farrokh Farhadi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tabriz University of Medical Sciences, Golgasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 6058 3553
Email
drfarrokhfarhadi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Farrokh Farhadi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tabriz University of Medical Sciences, Golgasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 6058 3553
Email
drfarrokhfarhadi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Farrokh Farhadi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tabriz University of Medical Sciences, Golgasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 6058 3553
Email
drfarrokhfarhadi@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
Not applicable
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