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IRCT20220407054442N1 IRCT 2022-07-30 Shahre-kord University of Medical Sciences Comparison of prophylactic effect single-dose Celecoxib and Mefenamic acid Comparison of prophylactic effect of single-dose Celecoxib and Mefenamic acid in reducing pain after tooth extraction 2022-07-01 anticipated 150 Complete https://irct.ir/trial/62840 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization will be done by permutation blocks with the size of each block equal to 6. The randomization list is provided by Random Allocation software There will be a person who is not among the collaborators of the project and does not know about the content of the interventions. Medicines in two categories A and B are given to the patient. In addition, the patient is told that one of the two studied drugs will be given to him, but it will not be clear which of the two drugs will be given to him. The obtained results will be presented to the statistical expert in the form of two groups A and B. Therefore, in this study, the operator, the patient and the statistical expert are blinded, Blinding description: The patient is told that one of the two drugs celecoxib or mefenamic acid will be given at random to relieve and prevent pain after tooth extraction. On the other hand, the assistant of the agent will randomly give one of these two drugs, which are in the same boxes and named as A and B and their type is unknown, to the patient, without informing the group type to the agent. Reports will be given to the statistical expert in the form of two groups A and B. 2-3 Tooth extraction. Intervention 1: First intervention group: Patients that receiving a single dose of celecoxib 200 mg capsules. Intervention 2: second intervention group: Patients receiving a single dose of Mefenamic acid 250 mg capsules. Yes - There is a plan to make this available What will be shared: All information of the participants, including: age, gender, type of tooth extracted, type of medication used before tooth extraction, amount of pain felt by the person, date and time of the operation, is available after the person is not identified. When: Access starts 6 months after the results are published. To whom: The data of this study is available only for researchers working in academic and scientific institutions and students studying in these centers. Conditions: There are the following conditions for the benefit of individuals authorized to use the information published by this study: Be a member of researchers working in academic and scientific institutions or a student studying in these centers. The use of the information of this study for reference as well as review studies is unimpeded. Where to obtain: Applicants can apply for information in the following ways: Email to: amin1samimi@gmail.com Refer to the research department of Shahrekord University of Medical Sciences How to obtain: In order to access the information of this study, the applicant should send an e-mail to amin1samimi@gmail.com and if he does not receive a response within 7 working days, he should refer to the research department of Shahrekord University of Medical Sciences to receive the information. Comments:
public Amin Samimi
No. 9, Azeen borje building, Andisheh Blvd, Farhangian Town
Shahrekord Iran (Islamic Republic of) 8818618926 +98 31 3781 6798 amin1samimi@gmail.com Shahre-kord University of Medical Sciences scientific Amin Samimi
No. 9, Azeen borje building, Andisheh Blvd, Farhangian Town
Shahrekord Iran (Islamic Republic of) 8818618926 +98 31 3781 6798 amin1samimi@gmail.com Shahre-kord University of Medical Sciences Iran (Islamic Republic of) Patients over 14 years and of any sex who do not have a serious systemic disease and are classified in class 1 or 2 of The American Society of Anesthesiologists (ASA) will be included in this study. 14 years no limit Both Patients who referred for tooth extraction due to periodontal support problem will not be included in the study. Patients with symptoms of infection such as swelling, fever, pus discharge, and decreased mouth opening will also not be included in the study. Patients who need analgesics for any reason other than toothache will not be included in the study. Patients who have a history of taking any painkillers up to 12 hours before tooth extraction will not be included in this study. Patients with systemic physical or mental illness or at risk for infectious endocarditis, coagulation problems, local and systemic infections, known allergies to celecoxib or mefenamic acid, a history of asthma, or drug or alcohol addiction will not be included in this study. Patients who require severe surgical intervention to extract a tooth will not be included in this study. celecoxib is contraindicated in patients with heart problems. Therefore, patients with heart disease will not participate in this study. Treatment - Drugs Treatment - Drugs First intervention group: Patients that receiving a single dose of celecoxib 200 mg capsules second intervention group: Patients receiving a single dose of Mefenamic acid 250 mg capsules Pain score in Visual Analogue Scale score questionnaire. Timepoint: Measure the amount of pain in one, three and six hours after tooth extraction. Method of measurement: Visual Analogue Scale. Shahre-kord University of Medical Sciences Approved 2022-06-28 Research Ethics Committees of Shahrekord University of Medical Sciences No. 9, Azeen borje building, Andisheh Blvd, Farhangian Town Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)