Protocol summary

Study aim
Comparison of the effects of nasal dexmedetomidine and oral chloral hydrate on sedation in children during MRI
Design
Using the randomized block method, individuals are divided into two groups of 70 people and then the treatment is performed on them by the clinical caregiver. The study is an unblinded clinical trial, which is conducted as a four-way permutation block method in the rand function of Excel software.
Settings and conduct
Using a randomized block design, subjects were divided into two groups. The study was an unblinded clinical trial conducted at Al-Zahra Hospital using the rand function of Excel software for randomization.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children who are candidates for MRI who require sedation for any reason and whose parents have consented to participate in the study. Exclusion criteria: Patients with a history of respiratory disease, gastric ulcer or liver disease, treatment with drugs that interact with chloral hydrate or dexmedetomidine, the presence of a specific underlying disease that affects the interpretation of objectives such as sedation duration, any previous allergic reaction to chloral hydrate or dexmedetomidine.
Intervention groups
first group: Children in this group will receive 5% chloral hydrate syrup at a dose of 50-100 micrograms/kg orally 10 minutes before the operation. In addition, for chloral hydrate, an initial dose of 50 micrograms/kg is given. If sedation is not sufficient, the dose will be 100 micrograms/kg. In the second group: Children in this group will receive intranasal dexmedetomidine at a dose of 2-3micrograms/kg 10minutes before the operation. The prescribed dose will start with a dose of 2micrograms/kg and if sedation is not sufficient, one microgram/kg will be added.
Main outcome variables
Sedation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221108056446N15
Registration date: 2025-02-09, 1403/11/21
Registration timing: prospective

Last update: 2025-02-09, 1403/11/21
Update count: 0
Registration date
2025-02-09, 1403/11/21
Registrant information
Name
Mehdi Mahmoodkhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 913 686 3733
Email address
mahmoodkhani@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-02-19, 1403/12/01
Expected recruitment end date
2025-06-22, 1404/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effect of nasal dexmedetomidine and oral chloral hydrate on sedation of children during MRI
Public title
Nasal dexmedetomidine and oral chloral hydrate on sedation in children
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Children who are candidates for MRI and require sedation for any reason. The child's parents must consent to participate in the study.
Exclusion criteria:
Patients with a history of respiratory diseases Stomach ulcers or liver disease Treatment with drugs that interact with chloral hydrate or dexmedetomidine The presence of a specific underlying condition that affects the interpretation of goals such as duration of sedation Any previous allergic reaction to chloral hydrate or dexmedetomidine
Age
From 6 months old to 10 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
With the convenience sampling method, the referring individuals who are eligible for the study are randomly divided into two groups: case and control. In this study, the division of individuals is done using the four-way permutation block method. In this method, A represents the individual who receives the intervention and B represents the individual who is in the control group. Considering the four-way block, we give the AABB permutation code 0, the ABAB permutation code 1, ABBA code 2, BAAB code 3, BBAA code 4, and BABA codes 5 to 9. Then, using the random number table, we randomly select a starting point and then consider the numbers in rows or columns. Considering the order of the numbers in the table, we assign the corresponding permutation to each number we encounter. Finally, 70 people will be divided into two groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Esfahan University of Medical Sciences
Street address
Hazar Jarib Street, Azadi Square
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2025-01-09, 1403/10/20
Ethics committee reference number
IR.MUI.MED.REC.1403.430

Health conditions studied

1

Description of health condition studied
Sedation
ICD-10 code
T88.52
ICD-10 code description
Failed moderate sedation during procedure

Primary outcomes

1

Description
Sedation
Timepoint
Patients were examined every 5 minutes and then every 10 minutes for up to an hour.
Method of measurement
The AVPU scale is used to assess a child's level of alertness and sleepiness.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Chloral hydrate will be administered orally. Children in this group will receive 5% chloral hydrate syrup at a dose of 50-100 micrograms/kg orally 10 minutes before the procedure. In addition, for chloral hydrate, a dose of 50 micrograms/kg is initially given. If sedation is not sufficient, the dose will be 100 micrograms/kg.
Category
Behavior

2

Description
Control group: Nasal dexmedetomidine will be administered. Children in this group will receive intranasal dexmedetomidine at a dose of 2-3 micrograms/kg 10 minutes before surgery. The prescribed dose is started at 2 micrograms/kg and if sedation is not sufficient, 1 microgram/kg is added.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hussein Children's Hospital
Full name of responsible person
Mohamadreza Ghazavi
Street address
Imam Khomeini Street
City
Esfahan
Province
Isfehan
Postal code
81951-63381
Phone
+98 31 3386 6266
Fax
Email
ghazavi8147@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Asgari
Street address
Hazar Jarib Street, Azadi Square
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
mui@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
1
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
Esfahan University of Medical Sciences
Full name of responsible person
Mohamadreza Ghazavi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Imam Khomeini Street
City
Esfahan
Province
Isfehan
Postal code
81951-63381
Phone
+98 31 3386 6266
Email
ghazavi8147@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohamadreza Ghazavi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Imam Khomeini Street
City
Esfahan
Province
Isfehan
Postal code
81951-63381
Phone
+98 31 3386 6266
Email
ghazavi8147@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohamadreza Ghazavi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Imam Khomeini Street
City
Esfahan
Province
Isfehan
Postal code
81951-63381
Phone
+98 31 3386 6266
Email
ghazavi8147@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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