Comparison of Ketamin/Propofol (Ketofol) and Etomidate /Fentanyl (Etofen) combinations for procedural sedation and analgesia of anterior shoulder dislocation reduction in Emergency Department: A Randomized Clinical Trial

Comparison of Ketamin/Propofol (Ketofol) and Etomidate /Fentanyl (Etofen) combinations for procedural sedation and analgesia of anterior shoulder dislocation reduction in Emergency Department

A clinical trial with two parallel groups of Ketofol and Etofen, single-blind, randomized, phase 2 on 46 patients. The patients will be randomly assigned to one of the Ketofol or Etofen groups. Randomization is done using a table of random numbers and by the block randomization method.

This study is conducted on patients who referred to the emergency department of Shahid Bahonar Hospital in Kerman. The patients will be randomly assigned to one of the Ketofol or Etofen groups. According to the PSAs protocol, Ketofol with a dose of 0.75 mg/kg IV bolus of ketamine and propofol, etofen with a dose of 0.15 mg/kg IV bolus of etomidate and 0.15 µg/kg of fentanyl are given as starting doses. A repeat dose of 0.375 mg/kg ketamine and propofol every 3 minutes and 0.1 mg/kg etomidate every 2 minutes is given until adequate sedation is achieved.

Inclusion criteria: Adults between 18 and 50 years old with anterior shoulder dislocation Exclusion criteria: History of allergy to any of the drugs, underlying cardiovascular disease, lung diseases and nervous system diseases, history of current drug or stimulant abuse now or in the last month, associated fracture, neurovascular symptoms, patient dissatisfaction, associated diseases

According to the PSAs protocol, bolus of ketamine and propofol for Ketofol Group, bolus of etomidate and fentanyl for Etofen group are given as sedation.

Pain score; number of attempts for reduction ; length of stay in the emergency; Drug side effects;

The patients will be randomly assigned to one of the Ketofol or Etofen groups. Randomization is done using a table of random numbers and by the block randomization method and in blocks of 5 people. In this way, a number is blindly selected from the table of random numbers for each position, and the two digits on the right side of it, if they are between 1 and 46, will be assigned to that position. Each of the blocks of 5 people is assigned to one group (Ketofol or Etofen). The odd blocks belong to the Ketofol group and the even blocks belong to the Etofen group. Block positions are numbered (1 to 46). For example, the first case that is randomly assigned to Ketofol group will enter the number one position of the first block (the block related to Ketofol) and this process will be done until the positions are filled and the number of samples in the two groups will be equal. .

Ketamin and Fentanyl drugs are colorless and have no difference in color, and the patient does not know which compound is being injected. Propofol is milky. Etomidate is available in two milky and colorless forms. A milky etomidate is used for the study to be similar to Propofol. Therefore, in each of the study groups, a colorless compound + a milky compound is used, and the patient is unaware of the type of drug.

Measured variables are available after unidentifiable individuals.

Up to one year after publish results.

All people in the research centers.

Allowed for any use.

Seyed Mojtaba Habibi Khorasani mojista.1375@gmail.com

After contacting and knowing the identity of the person, information will be provided to them.