- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07455695
Temperature Changes During Sedated Pediatric Magnetic Resonance Imaging
March 3, 2026 updated by: Ahmet Murat Gul, Ankara Etlik City Hospital
Body Temperature Changes in Children Undergoing Magnetic Resonance Imaging Under Sedation
Magnetic resonance imaging (MRI) is widely used in pediatric patients and frequently requires sedation or general anesthesia.
Both sedation and MRI-related environmental factors may influence thermoregulation.
This prospective observational study aimed to evaluate body temperature changes in children undergoing MRI under sedation and to identify factors associated with these changes.
A total of 285 pediatric patients (ASA physical status I-III) were included.
Tympanic body temperature was measured immediately before sedation and after completion of MRI, and the temperature difference (ΔT) was calculated.
Demographic, clinical, and environmental variables were analyzed to determine predictors of temperature change.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
285
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ankara
-
Altındağ, Ankara, Turkey (Türkiye)
- Ankara Etlik City Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Pediatric patients younger than 18 years with ASA physical status I-III undergoing magnetic resonance imaging (MRI) under sedation between November 2023 and April 2024.
Description
Inclusion Criteria:
- Age <18 years.
- American Society of Anesthesiologists (ASA) physical status I-III.
- Scheduled to undergo clinically indicated magnetic resonance imaging (MRI) under sedation.
- Written informed consent obtained from parent.
Exclusion Criteria:
- Age ≥18 years.
- ASA physical status IV-V.
- Known allergy to anesthetic medications used for sedation.
- Unstable vital signs prior to MRI.
- Fever (body temperature ≥37.5°C) before MRI.
- Severe pulmonary or cardiovascular comorbidities.
- Requirement for advanced airway management (laryngeal mask airway or endotracheal intubation).
- Refusal or absence of parental consent.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Body Temperature (ΔT) Before and After MRI
Time Frame: From immediately before sedation to immediately after completion of MRI (approximately 20-80 minutes)
|
The difference between tympanic body temperature measured immediately before sedation and immediately after completion of MRI (post-MRI minus pre-MRI temperature), expressed in degrees Celsius (°C).
|
From immediately before sedation to immediately after completion of MRI (approximately 20-80 minutes)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Tympanic Body Temperature (ΔT)
Time Frame: From immediately before sedation (pre-MRI) to immediately after MRI completion (approximately 20-80 minutes).
|
Change in core body temperature measured at the tympanic membrane using a Braun Thermoscan Ear Thermometer PRO 6000 (accuracy ±0.2°C). ΔT is calculated as post-MRI temperature minus pre-MRI temperature. Unit of Measure: Degrees Celsius (°C) |
From immediately before sedation (pre-MRI) to immediately after MRI completion (approximately 20-80 minutes).
|
|
Regression Coefficient (B) for Continuous Body Temperature Change (ΔT, °C)
Time Frame: From immediately before sedation to immediately after completion of MRI (approximately 20-80 minutes)
|
Independent predictors of continuous body temperature change (ΔT, °C) will be evaluated using multivariable linear regression analysis.
In this model, ΔT (calculated as post-MRI minus pre-MRI tympanic temperature) will be entered as the dependent variable.
The following predefined variables will be included simultaneously as independent predictors: age group (0-2, 3-7, 8-17 years), sex (male/female), ASA physical status (I-III), body mass index (kg/m²), fasting duration (hours), MRI duration (minutes), MRI room temperature (°C), MRI room humidity (%), contrast administration (yes/no), presence of comorbidity (yes/no), malignancy (yes/no), and allergy history (yes/no).
|
From immediately before sedation to immediately after completion of MRI (approximately 20-80 minutes)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2023
Primary Completion (Actual)
April 30, 2024
Study Completion (Actual)
June 30, 2024
Study Registration Dates
First Submitted
February 22, 2026
First Submitted That Met QC Criteria
March 3, 2026
First Posted (Actual)
March 6, 2026
Study Record Updates
Last Update Posted (Actual)
March 6, 2026
Last Update Submitted That Met QC Criteria
March 3, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AEŞH-EK1-2023-555
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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