Comparison of efficacy and safety between dexmedetomedine and fentanyl for central venous catheter placement in pediatric intensive care unit (PICU)

ٍEvaluation of efficacy and safety of dexmedetomidine for central venous catheter placement in pediatric intensive care unit compared to fentanyl

Patients are divided into two groups 1 or 2 using random number generation software. Group 1 patients receive dexmededomedin intravenously at a dose of 1 mcg/kg for 10 minutes as a loading dose. Group 2 patients receive fentanyl at a dose of 1 mcg/kg for 10 minutes as a loading dose. For all patients during the catheter implantation, the infusion of these drugs is continued at a rate of 1 mcg/kg/hr. If sedation is insufficient (Ramsay Sedation Scale <4), the loading dose is repeated and the dose of drug infusion is doubled. In case of insufficient sedation for each patient, intravenous propofol is used at a dose of one mg per kg of body weight.

Pediatric intensive care unit of Sari Bu-Ali Sina Hospital

Children in need of central venous catheter placement in the pediatric intensive care unit age one month to 18 years old enter the study with the consent of the patient's guardian or guardian. Presence of bradycardia or hypotension, hypertension above 99% or apnea before the study, presence of cardiac conduction impairment in the ECG before drug administration, patients with ASA physical status classification IV, presence of renal failure, known heart failure, History of heart surgery and shock are excluded.

Group 1: Children receiving dexmedetomidine for placement of central venous catheter Group 2: Children receiving fentanyl for placement of central venous catheter

1) Determining the amount of sedation during the catheterization process by Ramsay Sedation Scale 2) Changes in blood pressure, heart rate, respiration rate and O2 saturation

By simple randomization, individuals who meet the inclusion criteria and have completed informed consent will be assigned to two groups. This is done by assigning a random number to each person entering the study with random number generation software (using www.random.org). If it is an odd number, the patient will be allocated in group 1 and if it is even the patient will be assigned to group 2. The randomization process is performed by the ward supervisor (who is independent of the principal investigators). Randomization is performed before a patient enters the study and then the intervention is assigned according to his or her group therapy.

If a central catheter is needed, it will be announced by the treating physician. he trained nurse prepares dexmedetomidine and fentanyl according to the random code obtained (individual or even), respectively. The nurse, knowing the type of medicine, provides it to the doctor after diluting and homogenizing it in the same syringe. The physician performs the catheterization without knowing the type of drug, and the outcome assessor evaluates and records the sedation-related indicators under the physician's supervision. After completing the procedure and recording the outcomes (maximum 0.5-1 hour), the type of drug used is determined and recorded in the patient's file.

All data is potentially shareable after unidentified individuals.

Access period starts 6 months after the results are published

Researchers in academic and scientific institutions

For information on the details of the study without doing new statistical analysis

Sending an email to mrrafati@mazums.ac.ir

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