Comparison of the effects of ketofol (Ketamine-Propofol mixture) with propofol on Transient agitation in children undergoing Adenotonsillectomy

Comparison of the effects of ketofol (Ketamine-Propofol mixture) with propofol on Transient agitation in children undergoing Adenotonsillectomy

Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 64 patients. A random number table will be used for randomization.

This study is performed in Razi Hospital of Birjand, South Khorasan Province. 64 patients were randomly divided into two groups of adenotonsillectomy receiving propofol and ketofol. Then the agitation of patients in both groups is evaluated by the nurse at 15, 30 minutes in the recovery room and 2, 4 and 6 hours after surgery in the ward. Postoperative complications in patients, including: the presence or absence of nausea, vomiting, as well as the Modified objective pain score will be evaluated.

Candidates for tonsillectomy (adenotonsillectomy) who referred to Razi Hospital in Birjand in 1400. Inclusion criteria include: patients with ASA class one and two, aged 3 to 9 years, without any kinds of addiction and requirement to prescribe any narcotic drugs in recovery phase as well as any known previous propofol allergy reactions. exclusion criteria are defined as having mental and behavioral disorders, a specific rare disease, Cerebral trauma ,intracranial mass or bleeding and any congenital heart diseases.

Intervention group 1, Patients receiving propofol made by Fresenius Kabi Company, Germany as a general intravenous anesthetic at a dose of 2 mg /kg daily before surgery. Intervention group 2, patients who receive ketofol (40 mg Ketamine made by Rotex Medica, Germany + 160 mg propofol 1%) as an intravenous anesthetic before surgery.

Agitation

Participants in the study will be randomly divided into two groups after intervention with two drugs called ketofol (A) or propofol (B) using the block randomization process. Firstly, various quadruple blocks are created using a sealed envelope (AABB, BBAA, ABAB, BABA, ABBA, and BABA). One of these blocks is selected randomly and according to the order mentioned in the selected block, patients will be divided into one of two groups , namely A or B. Then randomization would be performed for other patients in the similar way.

Outcome evaluator=the nurse who was not informed of the type of medication received by the children, performed the necessary evaluation 15 and 30 minutes after the surgery in the recovery room as well as 2,4 and 6 hours post surgery evaluation which were done in the ward. Then, the evaluation data will be submitted to the specific checklist designed for this purpose. The children participating in the study, are not informed of the anesthetic agents that were given to them. Because they are not conscious while going under anesthesia and their lack of information about these kinds of anesthetic agents. The analyst= the analyst does not have any information about the placement of people in the study and conducts analysis on data based on the codes defined by the study leader