Comparing the effect of intranasal ketamin and intranasal dexmedetomedin versus placebo on sedation,bleeding,pain & agitation in children undergoing adenotonsilectomy

Effects of intranasal ketamine and dexmedetomidine versus placebo on preoperative pediatric rest, intraoperative bleeding, restlessness and pain in patients undergoing adenotonsillectomy

A randomized, triple-blind, placebo-controlled clinical trial

In this study, children in need of elective adenotonsillectomy surgery were recruited at Besat Hospital in Hamedan in 1979. Patients were randomly divided into three groups of dexmedetomidine (D), ketamine (k) and placebo control (normal saline). (NS) are segmented. Patients were given 2 mg / kg dexmodetimidine or 5 mg / kg ketamine 30 minutes prior to induction of anesthesia and in the control group received 5 drops of 9% normal saline with 2 mg syringe when the child was present with their parents. Be. Medications are poured into both nostrils. Blood pressure, pulse rate, and Spo2 are measured every 15 minutes after the drug is administered until the patient leaves the recovery room.

Children 4 to 12 years old undergoing adenotonsillectomy surgery • Inclusion criteria 1. Age 4 to 12 years 2. Candidate for tonsillectomy 3. Patient class according to American Society of Anesthesiology (ASA) ratings one and two • Exclusion criteria 1. Drug sensitivity to ketamine or dexmedothymidine 2. Mental retardation 3. Hyperactivity 4. Psychiatric drug use 5. History of heart, kidney, liver disease 6. Any pathological problems in the nose 7. Patients returning to the operating room due to postoperative bleeding

• Intervention group 1: Intranasal ketamine 5 mg / kg • Intervention group 2: Intranasal dexmedothymidine 2 μg / kg • Comparison Group: Normal intranasal saline 2 cc

Assessment of relaxation before anesthesia, Relaxation was assessed 15 and 30 minutes before anesthesia using a standard questionnaire

For this purpose we will use the hexadecimal random blocks method. For this purpose, we produce six sheets of paper. On the two sheets the letter K means "Ketamin" and on the other two sheets the letter D "dexmedetomedin" and on the two sheets the letter P means Placebo. Mix the sheets together and place in a drawer. On referral to each eligible patient, one leaf was randomly drawn and assigned to one of three study groups according to this leaflet, whether K, D or P. It should be noted that the drawn sheets will not be returned to the drawer until all six sheets have been drawn. After randomly pulling out all six sheets, all sheets will be returned to the drawer and the same operation will continue for the next six patients until the desired sample size (93 patients) is reached.

In this study, the researcher first presents the necessary explanations to the child's father {patient's father}. In the drawer she receives from the nurse, the patient is left unaware of the chosen group. Questionnaires and surveys are carried out by the researcher to the end. The analyzer analyzes the data based solely on the three types of groups a, b, and c, and after receiving the information from the analyzer, the nurse determines the relationship between the groups at the end.

Individual data of study participants, after unidentifiable individuals, can be shared in most tables and graphs.

Start data access period 6 month after printing results

The data will be available to researchers working in academic and scientific institutions.

It is possible to use the data after obtaining the written consent of the researchers

Dr. Mohammad Hossein Bakhshai : bakhshaei@umsha.ac.ir Dr. Mohsen Zarei : drm.zarei@yahoo.com

If you send an email, the data request will be answered within a week.