Evaluation of the effect of Acetaminophen on hemodynamic changes during intubation in children undergoing hypospadias surgery

Determination of the effect of Acetaminophen on hemodynamic changes during intubation in children undergoing hypospadias surgery

Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 126 patients. R-statistical software is used for block randomization.

The present study will be performed in Bahonar Hospital in Kerman. After the patient enters the operating room, systolic blood pressure, diastolic blood pressure and heart rate are checked and recorded before induction of anesthesia, after induction of anesthesia and at 1, 3, 6 and 9 minutes after intubation with the patient monitoring system. After the operation, incidence of nausea and vomiting during the recovery and 6 hours after leaving the recovery is assessed by asking the child or parents of the child. In order to double-blind the study, patients and the person responsible for data collection are unaware of the intervention.

Inclusion criteria include children undergoing hypospadias surgery aged 2 to 7 years. Exclusion criteria included known allergy to Acetaminophen, renal or hepatic impairment, bleeding disorders, history of known cardiovascular or respiratory disease, history of seizures, neurological or neuromuscular disorders, History of chronic pain or use of pain medication, and also Predict hard intubation

In the intervention group, children received 15 mg / kg suppository Acetaminophen two hours before surgery, and in the control group, children did not receive Acetaminophen suppositories.

Reduce blood pressure fluctuations and heart rate during surgery.

Block randomization method is used to randomize people into two groups. In this way, quadruple blocks are used. In each quadruple blocks, 2 people are assigned to group A (intervention group) and 2 people to group B (control group); So we have six quadruple blocks consisting of AABB, ABAB, BBAA, BABA, ABBA, BAAB. From the blocks, one is first selected at random and according to its order, the samples are assigned to two groups (for example, if the BBAA block is selected, the first two patients are assigned to group B and the next two patients to group A). R statistical software is used for random block allocation. Unit of randomization is individual.

In order to double-blind the study, patients and the person responsible for data collection are unaware of the intervention. Patients are unaware of the type of intervention and the group in which they are due to their young age. Also, the person in charge of data collection who performs all data recording operations and question from the patient or the patient's companion is also unaware of the intervention and the group in which the patient is.