Comparing the effectiveness of melatonin with placebo in reducing the level of interleukin-6 in operated infants.

Since inflammation is one of the most common and debilitating side effects in children undergoing surgery and disrupts the quality of life of infants, it is necessary to provide drugs to reduce their inflammation, as melatonin relieves sleep and reduces inflammation, for this reason, to prove the hypothesis that melatonin can reduce We use this medicine to create an inflammatory response.

The study has a control group with a blinded and randomized parallel group in phase 3 on 40 patients and the rand function of Excel software was used for randomization.

The control group was prescribed melatonin 0.1 mg/kg for 3 days from the day before the operation to the day after the operation, and on the third day after the operation, the level of interleukin 6.esr.cr was measured, and the control group was given routine drugs with placebo (normal saline) at the same time. The amount of 0.1mg/kg is given, then the level of the mentioned inflammatory factors is measured.

The conditions for entering the study are the age limit of less than one month and have been hospitalized due to surgery, and have the consent of the family to enter the plan, and the conditions of not entering the hospitalization plan are not due to surgery, and in the case of surgery, serious problems such as sepsis, meningitis, corona, severe cardiopulmonary problems, abnormality have fatal and incurable diseases and lack of consent to enter the project.

The intervention on facial surgery babies, which is on the level of interleukin 6.esr.crp, and blood cultures of both the control group that receives melatonin and the control group that receives placebo is done before and after the operation.

Inflammatory factors/melatonin/interleukin 6/infants/reduction of inflammation

Simple randomization in the form of sequential production, where the number of subjects in each block is set to 4, and letters A are for the intervention group and letters B are considered for the control group. Finally, 20 samples (5 blocks) were produced in both groups A and B, then the cards containing the blocks were placed inside the standard envelope, thus concealing the allocation of compliance Based on the referral of eligible infants, an envelope will be taken by the researcher and the method of allocation will be determined.

Blinding of the clinical caregiver who gives the medicine to the newborns, who randomly put the medicine in the caregiver's possession and will not know the contents of the medicine, and the analyzer will not know about the contents of the envelope.

Patient information, including the rate of therapeutic response to melatonin to reduce the inflammatory factor in infants undergoing surgery, and how to use melatonin and placebo drugs, which are recorded by a questionnaire and finally analyzed, and the informed consent of the parents of the infants indicating that the company in the study can be shared, but the names of the participants in the study to protect the patient's privacy. It is not placed.

The beginning of the access period is after the end of the registration of the results.

It will be available for everyone

To access this study, use the keywords melatonin, interleukin-6 and surgery

Submit your requests by email to dr.elnaznobakht@gmil.com

The request should be sent to the email of the person responsible for the study