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IRCT20151020024625N14 IRCT 2021-06-18 Semnan University of Medical Sciences Evaluation of the effect of oral glucose solution for pain control during infant circumcision Evaluation of the effect of oral glucose solution for pain control during infant circumcision by ring method (Plastibell) 2021-06-22 anticipated 60 Complete https://irct.ir/trial/56316 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: For randomization, a block randomization method will be used. In the study, The allocation of samples is based on a random sequence provided by a statistical expert using statistical software. The block size will be 6. Meanwhile, the tool which is used for generating random-sequence blocks is a web-based software available at https://kitset.ir/numbers/random. 3 Pain of incision site. Intervention 1: Intervention group: Lidocaine 2% is injected at a dose of 2 mg/kg by ring block method. Then, after 3 minutes, 2cc of glucose solution 50% is orally feed. Circumcision is performed 5 minutes after the onset of anesthesia. Intervention 2: Control group: Lidocaine 2% is injected at a dose of 2 mg/kg by ring block method. Then, after 3 minutes, 2 cc of distilled water is orally feed. Circumcision is performed 5 minutes after the onset of anesthesia. Yes - There is a plan to make this available What will be shared: Anonymised data will be offered. When: After publishing of final report To whom: Researcher who working in academic institutions Conditions: Referees and competent people Where to obtain: For this purpose, the applicant can send an official correspondence. How to obtain: After verifying the applicant's position Comments:
public Mehrdad Zahmatkesh
Basidj Boulevard, Amin Ave.
Semnan Iran (Islamic Republic of) 3519899951 +98 23 3142 2252 mehrdadzahmatkesh@semums.ac.ir Semnan University of Medical Sciences scientific Setareh Soltany MD
Basidj Boulevard, Amin Ave.
Semnan Iran (Islamic Republic of) 3519899951 +98 23 3142 2120 setarehsoltany@yahoo.com Semnan University of Medical Sciences Iran (Islamic Republic of) Infant candidate for circumcision by placing a ring (Plastibell) 1 month 12 months Male There is not any exclusion criteria G89.18 Other acute postprocedural pain Treatment - Other Placebo Intervention group: Lidocaine 2% is injected at a dose of 2 mg/kg by ring block method. Then, after 3 minutes, 2cc of glucose solution 50% is orally feed. Circumcision is performed 5 minutes after the onset of anesthesia. Control group: Lidocaine 2% is injected at a dose of 2 mg/kg by ring block method. Then, after 3 minutes, 2 cc of distilled water is orally feed. Circumcision is performed 5 minutes after the onset of anesthesia. Pain score. Timepoint: Before and during circumcision, every one minute. Method of measurement: Neonatal Infant Pain Scale. Duration of crying. Timepoint: Before and during circumcision. Method of measurement: Measurment by chronometer. Semnan University of Medical Sciences Approved 2021-02-23 Ethics committee of Semnan University of Medical Sciences Central office of Semnan University of Medical Sciences, Basidj Boulevard Semnan Semnan Iran (Islamic Republic of)