Evaluation of the effect of local injection of Lidocain on post-tansilectomy pain in children aged 5 -12 years old

Determining the effect of local Injection of Lidocaine on reducing pain after tansillectomy in children

Clinical trial, randomized, parallel group design of 134 patients, triple blind

The present study is a Triple-Blind clinical trial that will be done at Persian Gulf Martyr’s Hospital, Bushehr, on 134 children aged 5 to 12 years old need tonsillectomy. For random allocation of patients, the surgeon uses a double block to divide the patients into two groups of intervention ( Lidocaine recipients) and control (Normal saline recipients). the patient, person evaluating pain and data analyzer will get full blindness on this study and only the surgeon will be fully informed.The Children's Hospital of Eastern Ontario Pain Scale, On this scale, 6 components, which include: crying, facial, child verbal, torso, touch and legs, are evaluated. During evaluation In each part there will be given 0 or 1+ or 2+ points in the various modes, except screaming mode in the cry section that has 3+ points. More points indicate more pain and discomfort. .

Inclusion criteria: 1.Age between 5-12 years, 2.Chronic tonsillitis or recurrent tonsillitis, 3.Severe tonsil hypertrophy causing mechanical obstruction Exclusion criteria: 1.Coagulation disorder, 2.Cardiovascular patients, 3.Disagreement of parents

In the intervention group: for patients before tansillectomy operation 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. Lidocaine injection following general anesthesia is performed once by the surgeon. In the control group: before tansillectomy operation, 2 cc normal saline will be injected as a placebo in the tonsillar bed.

Evaluation of pain after tonsillectomy

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.

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.

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

Yes, the data will become available 3 months after the results are printed

Yes, after the study is completed, data will be available for academic and research institutes

After the completion of the project, it will be specified

Yes, after publishing the results, you can receive documents or data by e-mail mosaddegh.med@gmail.com or phone number 00989178744511 (Ali Mossadegh).

The release plan is still unknown