Temperature Changes During Sedated Pediatric Magnetic Resonance Imaging

NCT07455695 | Completed

• 1 other identifier: AEŞH-EK1-2023-555
• Study Type: observational
• Target: 285
• Locations: 1 country
• Sites: 1

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.

Conditions

Magnetic Resonance Imaging; Body Temperature Changes; Pediatric Anesthesia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in Body Temperature (ΔT) Before and After MRI

  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 Outcomes (2)

• Change in Tympanic Body Temperature (ΔT)

  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)

  From immediately before sedation to immediately after completion of MRI (approximately 20-80 minutes)

Interventions

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.

Eligibility Criteria

• Age: 1 Day - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Altındağ, Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Body Temperature Changes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist

Study Record Dates

• First Submitted: February 22, 2026
• First Posted: March 6, 2026
• Study Start: November 1, 2023
• Primary Completion: April 30, 2024
• Study Completion: June 30, 2024
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

TU (1)