Evaluation and Comparison of the Effect of Intranasal Dexmedetomidine and Midazolam on Child’s Sedation and Cooperation During IV Cannulation Prior to Dental Anesthesia and Heart Rate Changes During Laryngoscopy: A Randomized Controlled Clinical Trial
Evaluation and Comparison of the Effect of Intranasal Dexmedetomidine and Midazolam on Child’s Sedation and Cooperation During IV Cannulation Prior to Dental Anesthesia and Heart Rate Changes During Laryngoscopy
Design
This is a randomized clinical trial with parallel design. The study will be conducted on 60 eligible children. Block randomization will be used for randomization, and participants will be allocated into two intervention groups.
Settings and conduct
This non-blinded study will be conducted at the Roozbeh Surgical Center in Isfahan. Before the study begins, the patient's heart rate will be recorded. Furthermore, child anxiety will be assessed using five behavioral indicators: physical activity, speech, facial expression, interaction with the environment, and parental dependence.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Informed Consent; Healthy children 3–5 years of age; Need for general anesthesia for dental treatments
Exclusion criteria:Having contraindications for general anesthesia and nasotracheal intubation on the day of procedure/surgery
History of hypersensitivity to midazolam or dexmedetomidine
Intervention groups
The first intervention group will receive intranasal dexmedetomidine (Exir Company, Iran) at a dose of 1.5 µg/kg body weight, administered 20 minutes before the induction of anesthesia. The second intervention group will receive intranasal midazolam (Exir Company, Iran) at a dose of 0.2 mg/kg body weight, administered 20 minutes before the induction of anesthesia.
Main outcome variables
Heartbeat; Sedation during venipuncture؛ Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100621004224N39
Registration date:2026-05-12, 1405/02/22
Registration timing:prospective
Last update:2026-05-12, 1405/02/22
Update count:0
Registration date
2026-05-12, 1405/02/22
Registrant information
Name
Nasser Kaviani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2858
Email address
kaviani@dnt.mui.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-05-20, 1405/02/30
Expected recruitment end date
2026-07-06, 1405/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and Comparison of the Effect of Intranasal Dexmedetomidine and Midazolam on Child’s Sedation and Cooperation During IV Cannulation Prior to Dental Anesthesia and Heart Rate Changes During Laryngoscopy: A Randomized Controlled Clinical Trial
Public title
Comparison of the Effect of Intranasal Dexmedetomidine and Midazolam on Child’s Sedation and Cooperation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed Consent
Healthy children 3–5 years of age
Need for general anesthesia for dental treatments
Exclusion criteria:
Having contraindications for general anesthesia and nasotracheal intubation on the day of procedure/surgery
History of hypersensitivity to midazolam or dexmedetomidine
Use of sedative or anxiolytic medications within 24 hours prior to the study
Severe obesity or severe underweight
Age
From 3 years old to 5 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization using the blocking method with blocks in sizes 6 and 9. For randomization, the site https://www.sealedenvelope.com is used. All codes are recorded on paper and stored in specific envelopes. Each of the generated codes is kept separately inside the envelope and the secretary gives one of these envelopes to the patient before the patient enters the doctor's room. Accordingly, the next patient code is not predictable. The doctor determines which treatments to perform based on the patient's code. Only the physician performing the intervention will be aware of the code assigned to the patient. After evaluating the outcome, based on the patient's name, the collected information will be linked to the assigned code.
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
Isfahan University of Medical Sciences, Ethics Committee of the Faculty of Medicine
Street address
Isfahan University of Medical Sciences, Hezar Jarib St..
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2026-04-27, 1405/02/07
Ethics committee reference number
IR.MUI.MED.REC.1405.042
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
Primary outcomes
1
Description
Anxiety
Timepoint
The beginning of the study and the end of the study
Method of measurement
Base on Modified Yale Preoperative Anxiety Scale
2
Description
Sedation during venipuncture
Timepoint
20 minutes after drug administration, at the same time as venipuncture
Method of measurement
Base on University of Michigan Sedation Scale
3
Description
Heartbeat
Timepoint
Before and after laryngoscopy
Method of measurement
Using monitoring
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group will receive intranasal dexmedetomidine (Exir Company, Iran) at a dose of 1.5 µg/kg body weight, administered 20 minutes before the induction of anesthesia.
Category
Treatment - Drugs
2
Description
The second intervention group will receive intranasal midazolam (Exir Company, Iran) at a dose of 0.2 mg/kg body weight, administered 20 minutes before the induction of anesthesia
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rouzbeh Surgery Center
Full name of responsible person
Nastaran Kaviani
Street address
Arbab St, Sheikh Sadouqi Crossroads
City
Isfahan
Province
Isfehan
Postal code
816581531
Phone
+98 31 3664 3012
Email
n.kavizni@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Mozhgan Mortazavi
Street address
Isfahan University of Medical Sciences, Hezar Jarib St..
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3071
Email
m.Mortazavi@gmail.com
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
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
Esfahan University of Medical Sciences
Full name of responsible person
Nastaran Kaviani
Position
Dental student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Isfahan University of Medical Sciences, Faculty of Medicine, Hezar Jarib St..
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3071
Email
n.kaviani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Naser Kavizni
Position
University faculty member
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Isfahan University of Medical Sciences, Faculty of Medicine, Hezar Jarib St..
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3071
Email
n.kaviani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Naser Kaviani
Position
University faculty member
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Isfahan University of Medical Sciences, Faculty of Medicine, Hezar Jarib St..
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3071
Email
n.kaviani@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD