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IRCT20220412054516N1 IRCT 2022-05-08 Mazandaran University of Medical Sciences Comparison of the effect of Caine P with topical benzocaine on reducing needle entry pain in palatal anesthesia A Comparison study of the effects of Caine P with topical benzocaine in reducing needle insertion pain in Palatal anesthesia in children 9 to 12 years 2022-05-22 anticipated 23 Complete https://irct.ir/trial/62925 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After selecting the samples with inclusion criteria and without exclusion criteria, the quadrants were divided into two groups by blocking method. Randomization was performed with Random allocation software. Based on this, 23 double blocks were created with the mentioned software and provided to the main executor, Blinding description: The patient and the dentist performing the treatment do not know which anesthesia was applied on which side. 3 Needle entry pain before palatal anesthesia injection. Intervention 1: Intervention group: quadrant receiving Caine P as local anesthesia before injection = with a cotton swab on one side of the jaw Caine P (2.5% lidocaine cream and 2.5% perilocaine similar to EMLA, product of IranNajo) will be applied by the injector. Injection will be done 5 minutes after local anesthesia with 2% lidocaine (manufactured by Daru Pakhsh) with a 30 gauge needle (manufactured by DENJECT) in a 3 mm area of ​​the free gingival margin and that the needle's bevel is facing the bone, and the needle goes inside the tissue till it is in contact with bone. The injection is given to achieve palatal anesthesia. After the injection, the VAS scale is shown to the patient to indicate the amount of pain. Measurements with the VAS will be performed only once per session. The average of these numbers will be recorded and the data will be analyzed. Intervention 2: Control group: quadrant receiving Benzocaine as local anesthesia before injection = with a cotton swab on one side of the jaw benzocaine (20% benzocaine gel from Master dent) will be applied by the injector. Injection will be done 5 minutes after local anesthesia with 2% lidocaine (manufactured by Daru Pakhsh) with a 30 gauge needle (manufactured by DENJECT) in a 3 mm area of ​​the free gingival margin and that the needle's bevel is facing the bone, and the needle goes inside the tissue till it is in contact with bone. The injection is given to achieve palatal anesthesia. After the injection, the VAS scale is shown to the patient to indicate the amount of pain. Measurements with the VAS will be performed only once per session. The average of these numbers will be recorded and the data will be analyzed. Yes - There is a plan to make this available What will be shared: Part of the data, such as information about the main outcome or the like, can be shared When: Access period starts 6 months after the results are published To whom: Study documents will be available only to researchers working in academic and scientific institutions Conditions: The use of data to carry out new research projects is permitted Where to obtain: To the e-mail address of the respondent, Mostafa Akbari: mostafa.akbari@mazums.ac.ir How to obtain: After reviewing the incoming emails, the data will be sent to the applicant. Comments:
public Mehdi Taghian
Office Unit 610, 6th Floor, Shahriar 3 Building, Farhang St, Sari
Sari Iran (Islamic Republic of) - +98 11 3330 5443 m.taghian@mazums.ac.ir Mazandaran University of Medical Sciences scientific Mehdi Taghian
Office Unit 610, 6th Floor, Shahriar 3 Building, Farhang St, Sari
Sari Iran (Islamic Republic of) - +98 11 3330 5443 m.taghian@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Children 9 to 12 years Children who need palatal anesthesia injections on both sides of the jaw Written consent was obtained from their parents They are cooperative They are systemically healthy 9 years 12 years Both At risk for Methemoglobinemia Allergic to benzocaine, lidocaine and prilocaine Y65.8 Other specified misadventures during surgical and medical care Treatment - Drugs Treatment - Drugs Intervention group: quadrant receiving Caine P as local anesthesia before injection = with a cotton swab on one side of the jaw Caine P (2.5% lidocaine cream and 2.5% perilocaine similar to EMLA, product of IranNajo) will be applied by the injector. Injection will be done 5 minutes after local anesthesia with 2% lidocaine (manufactured by Daru Pakhsh) with a 30 gauge needle (manufactured by DENJECT) in a 3 mm area of ​​the free gingival margin and that the needle's bevel is facing the bone, and the needle goes inside the tissue till it is in contact with bone. The injection is given to achieve palatal anesthesia. After the injection, the VAS scale is shown to the patient to indicate the amount of pain. Measurements with the VAS will be performed only once per session. The average of these numbers will be recorded and the data will be analyzed. Control group: quadrant receiving Benzocaine as local anesthesia before injection = with a cotton swab on one side of the jaw benzocaine (20% benzocaine gel from Master dent) will be applied by the injector. Injection will be done 5 minutes after local anesthesia with 2% lidocaine (manufactured by Daru Pakhsh) with a 30 gauge needle (manufactured by DENJECT) in a 3 mm area of ​​the free gingival margin and that the needle's bevel is facing the bone, and the needle goes inside the tissue till it is in contact with bone. The injection is given to achieve palatal anesthesia. After the injection, the VAS scale is shown to the patient to indicate the amount of pain. Measurements with the VAS will be performed only once per session. The average of these numbers will be recorded and the data will be analyzed. Pain after needle insertion before palatal anesthesia injection. Timepoint: 5 minutes after applying the local anesthetic cream. Method of measurement: Visual Analogue Scale. Mazandaran University of Medical Sciences Approved 2022-01-12 Ethics committee of Mazandran University of Medical Sciences Deputy of Research and Technology, Moallem Square, Sari Sari Mazandaran Iran (Islamic Republic of)