Comparison of the preventive effect of Apotel together with venous complex with the effect of Apotel alone, on the pain of patients after tonsillectomy surgery

Comparison of the preventive effect of Apotel along with intravenous B complex with Apotel alone on postoperative pain of tonsillectomy

Clinical trial with intervention group, parallel groups, double-blind, randomized, phase 3 on 64 patients, rand function of Excel software was used for randomization.

Place of study: Bandar Abbas Shahid Mohammadi Hospital. After being placed on the bed of the operating room, the patients of the first group received Apotel in the amount of 15 mg/kg along with normal saline serum (in a total volume of 100 ml in the microset) 10 minutes before induction of anesthesia, and the patients of the second group received Apotel in the amount of 15 mg/kg and B complex drug in the amount of (thiamin 100 mg, pyridoxine 100 mg and cyanocobalamine 1 mg) are taken as infusion at the same time. After tonsillectomy, patients are transferred to recovery. The pain intensity of the patients is recorded with the VAS score at 1, 6, 12 and 24 hours after the operation. Due to the double blind nature of the study, all information was provided by the anesthesia assistant and then It is registered in a special form by the physician's assistant without knowing about the grouping.

Inclusion criteria : Patients with ASA class 1 and class 2 , Age of patients Exclusion criteria: patients with previous congenital disease, allergy to any of the drugs used in the study, patients with ASA above class 2

The patients of the first group received Apotel drug 10 minutes before induction of anesthesia, and the patients of the second group received Apotel drug along with injectable B-complex drug at the same time in the form of infusion, starting 10 minutes before induction of anesthesia.

Pain intensity, vital signs including blood pressure, heart rate, arterial oxygen saturation

simple random sampling. Considering that the total number of participants in this study is 64 people, using Excel software, 32 random numbers are randomly selected from numbers 1 to 64 and are placed in group A, 32 numbers remain. The rest are in group B. 64 envelopes will be prepared and the patient's number will be placed on the envelope and the corresponding treatment group will be placed inside each envelope. Each patient will be opened in the order in which they enter the study and the drug group will be assigned to them. The operation of random allocation and preparation of envelopes will be done by a person who is not present in the hospital

In each of the groups, the desired drugs are injected into the patient by the anesthesiologist, but the information required for the research is recorded by the anesthesiologist who does not know how to prescribe the drugs and group the patients. Due to the double-blindness of the study, information is recorded in a special form by a physician's assistant who does not know how to prescribe drugs and group them.

Comparison of the preventive effect of Apotel together with venous complex, with the effect of Apotel alone, on the pain intensity of patients based on VAS at 1, 6, 12, 24 hours after the operation. Comparison of the preventive effect of Apotel together with intravenous complex B, with the effect of Apotel alone, on the intensity of patients' pain based on arterial oxygen saturation (SPO2), blood pressure, heart rate, the need for additional pain medication, and complications including nausea and vomiting. At 1, 6, 12, 24 hours after the operation . Also, regarding data sharing, it is worth mentioning that all potential data can be shared after de-identifying individuals.

One year after the publication of the article

The data will be available to researchers working in academic and scientific institutions, as well as people who are also working in the industry, if needed and after sending a request, they can access the data.

The conditions of using the data are that after making people unidentifiable, all the data can be shared, and the data can be used to conduct scientific and academic research and pharmaceutical investigations, as well as the use of data in industries. , by mentioning the main source of data, there is no obstacle

To the first author(Mohammadreza khorramvar) Mohamadreza7140@gmail.com Or send an email to the scientific responsible for the study (Hashem Jari Neshin) hjarineshin@hums.ac.ir

Email the first author and request the use of data(Mohammadreza Khorramvar) Mohamadreza7140@gmail.com Or send an email to the scientific responsible for the study (Hashem Jari Neshin) hjarineshin@hums.ac.ir