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Completed

NCT Number: NCT07455695

Temperature Changes During Sedated Pediatric Magnetic Resonance Imaging

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.

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Key information

Conditions

Body Temperature Changes Magnetic Resonance Imaging Pathological Conditions, Signs and Symptoms Pediatric Anesthesia Signs and Symptoms

Age range

1 day–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara Etlik City Hospital

Altındağ, Ankara, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sedation During MRI

Other

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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)

  2. 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).

Sponsors and collaborators

Lead sponsor

Ankara Etlik City Hospital

Other Gov

Registry information

Official study title

Body Temperature Changes in Children Undergoing Magnetic Resonance Imaging Under Sedation

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 6, 2026
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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