Determining the effect of oral melatonin to reduce the dose of intravenous opioid infusion in mechanically ventilated children of Mofid Hospital
Design
Clinical trial with parallel control group, double blinded, randomized, phase III trial on 44 patients. Patients will be divided into two groups A and B by the code holder.So the analysis is decoded in the second stage and the intervention and the control group are determined.
Settings and conduct
children aged 3 months to 12 years with a Glasgow index higher than 8, who are not treated with sedatives will be randomized, double-blinded (patients and operators) in parallel way and treated with midazolam infusion at the rate of 0.1-0.5 mg/kg/h and fentanyl at the rate of 1-5 μg/kg/h and melatonin 3 mg dissolved in 5% dextrose water or under the infusion of midazolam and fentanyl with the same dose and placebo in the form of 5% dextrose water.
Participants/Inclusion and exclusion criteria
Children under ventilator from 3 months to 12 years old will be included in the study during the first week of hospitalization.
Patients needing continuous infusion of muscle relaxants, needing to receive midazolam and fentanyl less or more than the mentioned doses based on the score, sedation, duration of mechanical ventilation for more than one week, NPO for more than one week, suffering from liver and kidney failure and a Glasgow score of less than 8 at enrollment will not be included in the study.
Intervention groups
First group: midazolam infusion, 0.1-0.5 mg/kg/hours, fentanyl 1-5 mac/kg/hours, and melatonin 3 mg dissolved in 5% DW orally through NGT. Second group: under midazolam and fentanyl infusion with the same doses and the placebo will be placed as DW5% alone.
Main outcome variables
Intravenous midazolam continuous infusion dose
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240518061831N1
Registration date:2024-07-09, 1403/04/19
Registration timing:registered_while_recruiting
Last update:2024-07-09, 1403/04/19
Update count:0
Registration date
2024-07-09, 1403/04/19
Registrant information
Name
Nasrin Ahmadizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2712 3850
Email address
ghazal10690@yahoo.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-06-19, 1403/03/30
Expected recruitment end date
2025-06-20, 1404/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of oral melatonin compared to placeto in the required dose of venous midazolam in children under mechanical ventilation
Public title
Melatonin supplementation and midazolam reduction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children under ventilator from 3 months to 12 years
At the first week of hospitalization
Exclusion criteria:
Need for continuous infusion of muscle relaxants
The need to receive midazolam and fentanyl less or more than the listed doses based on the score
Sedation
Mechanical ventilation more than one week
NPO more than one week
liver and kidney disorder
Glasgow Score less than 8 at the study entry
Age
From 3 months old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomized by block randomization method, 4 participants in each block into two groups. Drug and placebo are provided in the same packaging with non-sequential alphanumeric codes made by the software. At the time of admission, the patient's code will be determined by calling the person holding the code based on a random list, and that code will be given to the patient.
Blinding (investigator's opinion)
Double blinded
Blinding description
The clinical caregiver and the participant do not know about the grouping and will only participate in the study with the assigned codes. Data analysis will also be based on the codes.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Shahid Besheshti University of Medical Sciences
Street address
Velenjak, Shahid Shahriari Square, Student Blvd., Shahid Arabi Street, Shahid Beheshti University of Medical Sciences, Building No. 2, Second Floor
City
Tehran
Province
Tehran
Postal code
4631- 19395
Approval date
2024-04-15, 1403/01/27
Ethics committee reference number
IR.SBMU.MSP.REC.1403.001
Health conditions studied
1
Description of health condition studied
Intubated children
ICD-10 code
Z00.1
ICD-10 code description
Encounter for newborn, infant and child health examinations
Primary outcomes
1
Description
Intravenous midazolam continuous infusion dose
Timepoint
at the baseline and one week later
Method of measurement
Dose of Midazolam based on mg/kg/hr
Secondary outcomes
1
Description
Dose of interavenous opioid
Timepoint
at the baseline and one week later
Method of measurement
Dose of opioid drug based on µg/ kg/hr
2
Description
Patient's sedation score
Timepoint
at the baseline and one week later
Method of measurement
State Behavioral Scale
Intervention groups
1
Description
Intervention group: midazolam infusion at the rate of 0.1-0.5 mg/kg/hours and fentanyl at the rate of 1-5 mac/kg/hours and melatonin 3 mg dissolved in DW 5%و orally through NGT.
Category
Treatment - Drugs
2
Description
Control group: midazolam infusion at the rate of 0.1-0.5 mg/kg/hours and fentanyl at the rate of 1-5 mac/kg/hours and placebo as DW5%, orally through NGT.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mofid Hospital
Full name of responsible person
Seyedeh Narjes Ahmadizadeh
Street address
7th Floor, Bldg No.2, SBUMS, Arabi Ave, Velenjak St, Tajrish Sq., Tehran Province
City
Tehran
Province
Tehran
Postal code
4631- 19395
Phone
+98 21 2712 3850
Email
Dr.nahmadizadeh@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Behrooz Abtahi
Street address
7th Floor, Bldg No.2 SBUMS, Arabi Ave, Velenjak, Tajrish, Tehran Province
City
Tehran
Province
Tehran
Postal code
4631- 19395
Phone
+98 21 2243 9872
Email
sec.bms@acecr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Seyedeh Narjes Ahmadizadeh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
7th Floor, Bldg No.2, SBUMS, Arabi Ave, Velenjak St, Tajrish Square, Tehran Province
City
Tehran
Province
Tehran
Postal code
4631- 19395
Phone
+98 21 2712 3850
Email
Dr.nahmadizadeh@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Seyedeh Narjes Ahmadizadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
7th Floor, Bldg No.2 SBUMS, Arabi Ave, Velenjak St, Tajrish Square, Tehran Province
City
Tehran
Province
Tehran
Postal code
4631- 19395
Phone
+98 21 2712 3850
Email
Dr.nahmadizadeh@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Seyedeh Narjes Ahmadizadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
7th Floor, Bldg No.2 SBUMS, Arabi Ave, Velenjak St., Tajrish Square, Tehran province
City
Tehran
Province
Tehran
Postal code
4631- 19395
Phone
+98 21 2712 3850
Email
Dr.nahmadizadeh@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
It will be made available to the research and technology vice-chancellor of Shahid Beheshti University of Medical Sciences.
When the data will become available and for how long
after paper publication
To whom data/document is available
Researchers based on the request to the corresponding author of the paper
Under which criteria data/document could be used
For future studies and meta-analysis
From where data/document is obtainable
Shahid Chamran Highway - Yemen Street - Shahid Abbas Arabi Street (Parvaneh) - next to Taleghani Hospital - Shahid Beheshti University of Medical Sciences and Healthcare Services - Headquarters Building 2-
5th floor - Research and Technology Vice-Chancellor
telephone (direct): 021, 22439780/81
Fax: 021, 22439981
What processes are involved for a request to access data/document
request by the electronic e-mail to the Dr. Narjes Ahmadizadeh under the email address Dr.nahmadizadeh@sbmu.ac.ir