Comparison of effectiveness of dexmedetomidine plus Midazolam and fentanyl plus Midazolam in placement of central venous catheter in Pediatric Intensive Care Unit (PICU)
Comparing the effectiveness of "dexmedetomidine and midazolam" with "fentanyl and midazolam" in the speed of achieving sufficient sedation, determining the amount of drug needed to achieve sufficient sedation, determining hemodynamic changes in central venous catheter placement in the Pediatric Intensive Carr Unit (PICU)
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 50 patients
Settings and conduct
This randomized clinical trial is conducted to compare the effectiveness of dexmedetomidine and midazolam with fentanyl and midazolam in central venous catheter placement in the PICU of BuAli Hospital. People are randomly selected by age block and divided into two intervention and control groups in parallel. Dexmedetomidine and fentanyl drugs are prepared and coded in 10 cc syringes in the same composition by the pharmacist on the days when the patient needs catheterization. The patient and the researchers do not know the type of contents of the syringes.
Participants/Inclusion and exclusion criteria
Children 1 month to 18 years needing central venous catheter placement in the PICU are included
Intervention groups
In the intervention group, 1 μg/kg intravenous dexmedetomidine is prescribed for ten minutes along with 0.1 mg/kg injectable midazolam as a loading dose. Dexmedetomidine infusion continues at a rate of 1 μg/kg/hour.
The control group recieves the general protocol of the PICU of BuAli Hospital and for sedation, receives fentanyl at a dose of 1 μg/kg for 10 minutes along with midazolam at a dose of 0.1 mg/kg during the procedure. Fentanyl infusion continues at a rate of 1 μg/kg/h.
Main outcome variables
Primary outcome: reaching Ramsay Sedation Scale (RSS) equal to 3 or more; Secondary outcome: end of catheterization
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230701058628N2
Registration date:2023-07-27, 1402/05/05
Registration timing:registered_while_recruiting
Last update:2023-07-27, 1402/05/05
Update count:0
Registration date
2023-07-27, 1402/05/05
Registrant information
Name
Mohammad Reza Navaeifar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3334 2334
Email address
m.navaeifar@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-21, 1402/01/01
Expected recruitment end date
2023-09-22, 1402/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effectiveness of dexmedetomidine plus Midazolam and fentanyl plus Midazolam in placement of central venous catheter in Pediatric Intensive Care Unit (PICU)
Public title
Comparison of effectiveness of dexmedetomidine plus Midazolam and fentanyl plus Midazolam in placement of central venous catheter in PICU
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Children needing central venous catheter placement in the pediatric intensive care unit
Exclusion criteria:
Presence of bradycardia or hypotension
High blood pressure above the 99th percentile
Apnea before the study
The presence of cardiac conduction disorder in the electrocardiogram before drug administration
Patients with American Society of Anaesthesiologists' physical status classification III or higher
Known kidney or heart failure
History of heart surgery
Shock
Receiving other anesthetics, sedatives, injectable painkillers
Age
From 1 month old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
After meeting the inclusion criteria for the study, randomization is done by simple randomization method with age block. Dexmedetomidine and fentanyl drugs are similarly prepared and coded in a 10 mL syringe by a pharmacist and provided to the researcher. The patient and the treatment team will not know the nature of the contents of the syringes, and the desired syringe will be delivered to the treatment team daily based on the initial group determined. Only at the end of the study or in case of a complication that requires therapeutic intervention and knowing the name of the drug, the drug code is decoded by the researcher and the name of the drug is provided to the doctor. Before assigning the individuals in groupa, the assigned group is not clear.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be conducted in a double-blind manner. Dexmedetomidine and fentanyl drugs are similarly prepared and coded in a 10 mL syringe by a pharmacist and kept in the refrigerator until use. The patient, the prescribing nurse and the doctor are not aware of the type of therapeutic combination used. Only at the end of the study or in case of a complication that requires therapeutic intervention and knowing the name of the drug, the drug code is decoded by the researcher and the name of the drug is provided to the doctor.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Pediatric Infectious Diseases Research Center, Buali Hospital, Pasdaran Boulevard, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
4815838477
Approval date
2023-01-24, 1401/11/04
Ethics committee reference number
IR.MAZUMS.REC.1401.504
Health conditions studied
1
Description of health condition studied
Viral infection
ICD-10 code
B34
ICD-10 code description
Viral infection of unspecified site
2
Description of health condition studied
Acute lower respiratory infection
ICD-10 code
J22
ICD-10 code description
Unspecified acute lower respiratory infection
3
Description of health condition studied
Virus infections of central nervous system
ICD-10 code
A81
ICD-10 code description
Atypical virus infections of central nervous system
4
Description of health condition studied
Immunodeficiency
ICD-10 code
D84.9
ICD-10 code description
Immunodeficiency, unspecified
5
Description of health condition studied
Renal failure requiring dialysis or plasmaphresis
ICD-10 code
P96.0
ICD-10 code description
Congenital renal failure
Primary outcomes
1
Description
Ramsay Sedation Score equal to or more than 3
Timepoint
Every 5 minutes until 5 minutes after sedation
Method of measurement
Ramsay scale
2
Description
Mean arterial blood pressure
Timepoint
Every 5 minutes until 5 minutes after sedation
Method of measurement
Blood pressure monitor
3
Description
Blood oxygen saturation
Timepoint
Every 5 minutes until 5 minutes after sedation
Method of measurement
Palsoxymeter
4
Description
Heart rate and respiratory rate
Timepoint
Every 5 minutes until 5 minutes after sedation
Method of measurement
تعداد در دقیقه
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, 1 μg/kg intravenous dexmedetomidine is prescribed for ten minutes along with 0.1 mg/kg injectable midazolam as a loading dose. Dexmedetomidine infusion continues at a rate of 1 μg/kg/hour.
Category
Treatment - Drugs
2
Description
Control group: The control group recieves the general protocol of the Pediatric Intensive Care Unit (PICU) of BuAli Hospital and for sedation, receives fentanyl at a dose of 1 μg/kg for 10 minutes along with midazolam at a dose of 0.1 mg/kg during the procedure. Fentanyl infusion continues at a rate of 1 μg/kg/h.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Buali Hospital
Full name of responsible person
Dr. Mohammad Reza Navaeifar
Street address
Pediatric Infectious Diseases Research Center, Buali Hospital, Pasdaran Boulevard, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 911 325 2944
Email
m.navaeifar@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Pedram Ebrahimnejad
Street address
Vice chancellor for Research, Moallem square, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
4712855689
Phone
+98 11 3448 4800
Email
pebrahimnejad@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Fahimeh Dianati
Position
Resident of Pediatrics
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Pediatric Infectious Diseases Research Center, Buali Hospital, Pasdaran Boulevard, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 2334
Email
pidrc@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mohammad Reza Navaeifar
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Pediatric Infectious Diseases Research Center, Buali Hospital, Pasdaran Boulevard, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 2334
Fax
Email
m.navaeifar@mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Fahimeh Dianati
Position
Resident of Pediatrics
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Pediatric Infectious Diseases Research Center, Buali Hospital, Pasdaran Boulevard, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 2334
Email
pidrc@mazums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)