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Temperature Changes During Sedated Pediatric Magnetic Resonance Imaging

Body Temperature Changes in Children Undergoing Magnetic Resonance Imaging Under Sedation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07455695
Enrollment
285
Registered
2026-03-06
Start date
2023-11-01
Completion date
2024-06-30
Last updated
2026-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Body Temperature Changes, Magnetic Resonance Imaging, Pediatric Anesthesia

Keywords

Pediatric Anesthesia, Sedation, Magnetic Resonance Imaging, Body Temperature Changes, Pediatric Patients

Brief summary

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.

Interventions

OTHERSedation During MRI

This is a prospective observational study. No experimental intervention was applied. All pediatric patients underwent routine sedation for clinically indicated MRI procedures according to institutional standard practice. The study evaluated body temperature changes before and after MRI without modifying clinical management.

Sponsors

Ankara Etlik City Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 17 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Body Temperature (ΔT) Before and After MRIFrom 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).

Secondary

MeasureTime frameDescription
Change in Tympanic Body Temperature (ΔT)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)
Regression Coefficient (B) for Continuous Body Temperature Change (ΔT, °C)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).

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026