Comparison of Efficacy of Intranasal versus Intravenous Dexmedetomidine for Procedural Sedation in Pediatric Patients Undergoing Magnetic Resonance Imaging
To compare the outcomes of intranasal versus intravenous dexmedetomidine for procedural sedation in pediatric patients undergoing MRI.
Design
Non Randomized Control Trial
Settings and conduct
Setting: Department of Radiology and Imaging
Conduct: Data will be collected prospectively after approval of the synopsis, from eligible children aged 1 month–12 years requiring MRI under sedation, following pre-anesthesia assessment and written informed consent. Participants will be consecutively allocated by alternate assignment into Group A (intranasal dexmedetomidine, n=63) and Group B (intravenous dexmedetomidine, n=63). Standard monitoring will be applied, and sedation depth will be assessed every 5 minutes using the University of Michigan Sedation Scale (UMSS), with MRI initiated once UMSS ≥2 is achieved. Sedation onset time, duration, physiological parameters, rescue sedation requirements, and adverse events will be recorded. Failure to achieve adequate sedation within 20 minutes or significant movement during MRI requiring rescue sedation will be considered primary sedation failure
Participants/Inclusion and exclusion criteria
INCLUSION CRITERIA: Children aged 1 month to 12 years scheduled for elective MRI. American Society of Anesthesiologists (ASA) physical status I and II.
EXCLUSION CRITERIA: Known allergy to dexmedetomidine. Contraindications to dexmedetomidine (cardiac failure, cardiac arrhythmias, long QT syndrome, baseline bradycardia or hypotension, use of beta-blockers or digoxin, uncontrolled arterial hypertension, or recent stroke/intracranial bleeding). For the intranasal group only: children with URTI or nasal blockage within the preceding two weeks, as this alters mucosal drug absorption.
Intervention groups
Two Groups.
Group A for Intranasal Rout
Group B for Intravenous rout
Main outcome variables
Onset time
Duration
Recovery time
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260824070775N1
Registration date:2026-09-02, 1405/06/11
Registration timing:prospective
Last update:2026-09-02, 1405/06/11
Update count:0
Registration date
2026-09-02, 1405/06/11
Registrant information
Name
Hassaan Ghani
Name of organization / entity
Combined military Hospital
Country
Pakistan
Phone
+92 317 1669946
Email address
hassaan.ghani.gb@gmail.com
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2026-11-01, 1405/08/10
Expected recruitment end date
2027-04-30, 1406/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Efficacy of Intranasal versus Intravenous Dexmedetomidine for Procedural Sedation in Pediatric Patients Undergoing Magnetic Resonance Imaging
Public title
Comparison of Efficacy of Intranasal versus Intravenous Dexmedetomidine for Procedural Sedation in Pediatric Patients Undergoing Magnetic Resonance Imaging
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Children aged 1 month to 12 years scheduled for elective MRI. American Society of Anesthesiologists (ASA) physical status I and II
Exclusion criteria:
Known allergy or previous anaphylaxis to dexmedetomidine. Contraindications to dexmedetomidine (cardiac failure, cardiac arrhythmias, long QT syndrome, baseline bradycardia or hypotension, use of beta-blockers or digoxin, uncontrolled arterial hypertension, or recent stroke/intracranial bleeding). For the intranasal group only: children with an upper respiratory tract infection or nasal blockage within the preceding two weeks, as this alters mucosal drug absorption
Age
From 1 month old to 12 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
126
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee Pak Emirates Military Hospital Rawalpindi
Street address
Mall Road Rawalpindi
City
Rawalpindi
Postal code
46000
Approval date
2026-01-07, 1404/10/17
Ethics committee reference number
A/28/04/26
Health conditions studied
1
Description of health condition studied
Procedural Sedation. Procedural anxiety
ICD-10 code
F13.90
ICD-10 code description
Sedative, hypnotic, or anxiolytic use, unspecified, uncomplicated
Primary outcomes
1
Description
Onset of Sedation
Timepoint
Baseline (pre-sedation), every 5 minutes during the drug onset period
Method of measurement
The University of Michigan Sedation Scale (UMSS)
2
Description
Duration of Sedation
Timepoint
every 5 minutes after the drug onset period till completion of the MRI scan
Method of measurement
The University of Michigan Sedation Scale (UMSS)
3
Description
Recovery Time
Timepoint
every 5 minutes in the post-sedation recovery unit until the patient returns to baseline status (UMSS score 0)
Method of measurement
The University of Michigan Sedation Scale (UMSS)
Secondary outcomes
1
Description
Incidence of Treatment-Related Adverse Events like Bradycardia and hypotension
Timepoint
Baseline (pre-sedation), every 5 minutes during the MRI scan, and every 15 minutes in the recovery unit until discharge
Method of measurement
Tracking the frequency of specific clinical events, including bradycardia (heart rate lower than age-adjusted normal limits), hypotension (blood pressure lower than age-adjusted normal limits)
Intervention groups
1
Description
Intranasal dexmedetomidine group: Dexmedetomidine at a dose of 2–3 µg/kg will be administered as nasal drops divided equally between both nostrils approximately 30–45 minutes before imaging. The child will be kept in a supine position for 1–2 minutes to optimize mucosal absorption, and the dose may be repeated up to a maximum of 200 µg if necessary.
Category
Treatment - Drugs
2
Description
Intravenous dexmedetomidine group: Venous access will be secured by phlebotomist (more than 5 years of experience) and dexmedetomidine will be administered as a loading dose of 0.5–2 µg/kg over 10 minutes, followed by a maintenance infusion of 0.5–1.5 µg/kg/hour, adjusted according to the required level of sedation
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Pak Emirates Military Hospital Rawalpindi
Full name of responsible person
Hassaan Ghani
Street address
House 11 Street 3 New Harley Street Rawalpindi
City
Rawalpindi
Postal code
408000
Phone
+92 317 1669946
Email
hassaan.ghani.gb@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Pak Emirates Military Hospital Rawalpindi
Full name of responsible person
Hassaan Ghani
Street address
House 11 Street 3 New Harley Street Rawalpindi
City
Rawalpindi
Postal code
408000
Phone
+92 317 1669946
Email
hassaan.ghani.gb@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pak Emirates Military Hospital Rawalpindi
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
Pak Emirates Military Hospital Rawalpindi
Full name of responsible person
Hassaan Ghani
Position
Post Graduate Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
House 11 Street 3 New Harley Street Rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
408000
Phone
+92 317 1669946
Email
hassaan.ghani.gb@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Pak Emirates Military Hospital Rawalpindi
Full name of responsible person
Hassaan Ghani
Position
Post Graduate Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
House 11 Street 3 New Harley Street Rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
408000
Phone
+92 317 1669946
Email
hassaan.ghani.gb@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Pak Emirates Military Hospital Rawalpindi
Full name of responsible person
Hassaan Ghani
Position
Post Graduate Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
House 11 Street 3 New Harley Street Rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
408000
Phone
+92 317 1669946
Email
hassaan.ghani.gb@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
Individual participant data will not be shared outside the primary research team due to institutional policy and patient privacy restrictions governing pediatric medical records. Aggregate results will be made fully available through publication