]>
IRCT20180825040859N1 IRCT 2019-01-16 Boushehr University of Medical Sciences Evaluation of the effect of localized Lidocaine Injection on post-tansilectomy pain Evaluation of the effect of local injection of Lidocain on post-tansilectomy pain in children aged 5 -12 years old 2019-01-30 anticipated 134 Complete https://irct.ir/trial/33498 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Among the patients referring to the elective tansillectomy, the population of the sample was selected as simple sampling based on the satisfaction of the company in the study. For random allocation, the participants were divided into two groups of intervention (lidocaine receptor) and control group (normal saline recipients) using four balanced blocks. Random sequence generation is done using Excel software and the size of all blocks is equal. To blind patients after describing the goals of the study and obtain written consent for participation in the study, participants are divided into intervention recipient groups and control groups without any knowledge of the patient of the type of intervention by block method (by assigning different codes). After performing the intervention by the researcher, to assess the severity of pain in patients, the outcome evaluator was not aware of the type of intervention performed and evaluated the patients with the assigned codes. When analyzing data, the data analyzer does not know the partitioning of the groups and the codes assigned to them, and the comparisons are performed under two unspecified groups, Blinding description: In this study, only the surgeon (project executive) knew the type of intervention and patients, the person assessing the severity of pain and the person analyzing the information, are not aware of the type of intervention group or control group. To blind patients after describing the goals of the study and obtain written consent for participation in the study, participants are divided into intervention recipient groups and control groups without any knowledge of the patient of the type of intervention by block method (by assigning different codes). After performing the intervention by the researcher, to assess the severity of pain in patients, the outcome evaluator was not aware of the type of intervention performed and evaluated the patients with the assigned codes. When analyzing data, the data analyzer does not know the partitioning of the groups and the codes assigned to them, and the comparisons are performed under two unspecified groups. 3 Pain control after tonsillectomy. Intervention 1: Intervention group: before tonsillectomy, once using lidocaine ampoule of 20 mg/ml from Darou Pakhsh company, will be injected at the dose of 1 mg/kg in the tonsillar bed. Intervention 2: Control group: Before tansillectomy , 2 cc normal saline will be injected as a placebo in the tonsillar bed. Yes - There is a plan to make this available What will be shared: Yes, the title of the study and how the study is carried out will be published in the form of medical ethics once the results of the study are published When: Yes, the data will become available 3 months after the results are printed To whom: Yes, after the study is completed, data will be available for academic and research institutes Conditions: After the completion of the project, it will be specified Where to obtain: Yes, after publishing the results, you can receive documents or data by e-mail mosaddegh.med@gmail.com or phone number 00989178744511 (Ali Mossadegh). How to obtain: The release plan is still unknown Comments:
public Ali Mosaddegh
Shahid Keshtekar Ave, Khoshab Village, Borazjan Town
Borazjan Iran (Islamic Republic of) 7561146551 +98 77 3437 2670 mosaddegh.med@gmail.com Boushehr University of Medical Sciences scientific Allahkaram Akhlaghi
unit 16, Fatemeh Al Zahra Doctors' Hospital, Moallem Squ
Bushehr Iran (Islamic Republic of) 7517933755 +98 77 3332 9190 akhlaghidr@gmail.com Boushehr University of Medical Sciences Iran (Islamic Republic of) Age between 5-12 year's old Chronic tonsillitis or recurrent tonsillitis Peritonsillar abscess Tonsillogenic septicemia Focal symptoms following tonsillitis Severe tonsil hypertrophy causing mechanical obstruction Suspicious to tonsil tumor Resistant carriers of diphtheria bacilli Bad and resistant mouth odor due to the high production of tonsillar plaques Tuberculous lymphadenitis, in which the tonsils are possible entry point 5 years 12 years Both Metabolic disorders Coagulopathy Mental retardation Developmental dysfunction Drug allergy Psychotic disorders Chronic pain and those who received analgesic Heart patients Disagreement of the parents with their child's participation in the study J35.1 Hypertrophy of tonsils Treatment - Drugs Placebo Intervention group: before tonsillectomy, once using lidocaine ampoule of 20 mg/ml from Darou Pakhsh company, will be injected at the dose of 1 mg/kg in the tonsillar bed. Control group: Before tansillectomy , 2 cc normal saline will be injected as a placebo in the tonsillar bed. Post tonsillectomy pain based on Children's Hospital of Eastern Ontario Pain Scale. Timepoint: In the minutes 15, 30, 60, 120, 240, 360 after tonsillectomy. Method of measurement: Children's Hospital of Eastern Ontario Pain Scale. Boushehr University of Medical Sciences Approved 2018-08-21 Ethics committee of Bushehr University of Medical Sciences Bushehr University of Medical Sciences, Salman Farsi Ave, Rishehr, Bushehr Bushehr Boushehr Iran (Islamic Republic of)