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

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.

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

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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