Study of Acetaminophen and Dexamethasone effects on agitation in children undergoing tonsillectomy

1- Comparison of the effect of acetaminophen and dexamethasone on the rate of restlessness of children undergoing tonsillectomy. 2- Comparison of the effect of acetaminophen and dexamethasone on the degree of restlessness of children undergoing tonsillectomy based on age 3- Comparison of the effect of acetaminophen and dexamethasone on the degree of restlessness of children undergoing tonsillectomy by sex 4. Comparison of the effect of acetaminophen and dexamethasone drugs on the mean pain of children undergoing tonsillectomy

In this study, 140 children undergoing tonsillectomy Referring to Khatam-al-Anbia Hospital in Zahedan having the inclusion criteria and double-blinded in phase 3 trial enters the study and divided into four categories with Simple random method And the codes are assigned to them.

Children aged 2 to 7 years undergoing tonsillectomy referring to Khatam Al-Nabia Hospital enters the study. Blinding double-blind method will be use and study groups members and expert statistical will not know the details of study groups.

Inclusion criteria: age 2 to 7 years, undergo tonsillectomy operation, parental consent for children Conditions not included in the study: taking previous medications (remove all previous medications 2 hours before surgery)

Group 1: Dexamethasone and acetaminophen placebo (Dexamethasone intravenously and 0.2 mg / kg in addition with 0.25 mg / kg of syrup with strawberry flavor). Group 2: Acetaminophen and placebo of Dexamethasone (20 mg / kg) Acetaminophen with 0.5 ml / kg of normal saline serum. Group 3: Acetaminophen and Dexamethasone (20 mg / kg acetaminophen syrup) and dexamethasone intravenously (0.2mg / kg) ). Group 4: Dexamethasone placebo and acetaminophen placebo (0.5ml / kg of normal saline plus 0.25mg / kg of syrup with strawberry flavor). Monitoring and control starts in the operation room, which includes the electrocardiogram, Pulse oximetry and blood pressure. After preoxygenation with 100% oxygen by mask, induction of anesthesia with atropine 0.01 mg / kg, 2 micg / kg fentanyl, 5 mg / kg sodium thiopental and 0.5 mg / kg atracurium. The tracheal intubation will performed and the immobilization will performed with 66% N2O at 33% O2 ​​and 1/2 MAC of isoflurane. The number of breathing ventilators with CO2 output will set to between 35 mmHg and 45 mmHg. Morphine will injected 0.1 ml / kg intravenously to all patients after the endotracheal fixation. Each 1 ml of blood lost replaced with 3 ml of ringer lactate serum . When the child is able to open his eyes and keep the head up for 5 seconds, the tracheal tube will be out. In The PICU section, the children's restlessness will measured by Richmond Agitation Sedation Score after passing 10, 20 and 30 minutes of the extubation of the tube.

agitation : after intervention . After receiving the medication, the Richmond Agitation Sedation Score in the PICU section of the children's restraint is measured after 10, 20, and 30 minutes after the removal of the tracheal tube. (0: alert and quiet, 1: restless, 2: disturbed, 3: very disturbed and 4: controversy and fights) and pain is measured by Face Scale.

Investigator

The randomization and the entry of the statistical community into each intervention or control group will be based on the selection of colored papers, so that we will have four colors of blue, green, yellow and red papers for the sample size. Those who take the blue paper will enter the intervention group, those who take the green paper will go into the control group with the acetaminophen placebo, those who take the yellow paper will go into the control group with the dexamethasone placebo, and the those who take the red paper will enter the control group with the Both the placebo.

Each member of the control and intervention groups will not aware of the fact that they will receive the medication or placebo. The statistician will also analyze the data with coding so that he will also not aware that which data is related to the control group and which data will be related to the intervention group.