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Emergence Delirium in Children for Magnetic Resonance Imaging

NCT04816344 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 140

Last updated 2021-04-01

No results posted yet for this study

Summary

Sedation or anaesthesia is necessary to be able to perform magnetic resonance imaging (MRI) on children who cannot keep still or are uncooperative, and thus the targets of maximum patient safety, successful imaging, and the highest imaging quality can be achieved. There are various drugs for sedation in MRI. A child with Anaesthesia Emergence Delirium (AED) has a state of consciousness which can be described as "irritable, uncompromising, inconsistent, crying inconsistently, wailing, and kicking". The incidence of AED worldwide has been reported to vary between 18% and 80%, depending on the diagnostic criteria used. This difference can usually be explained by the use of different scales and defining criteria. In 2004, Sikich and Lerman developed the Paediatric Anaesthesia Emergence Delirium (PAED) scale, including cognitive evaluation components in addition to agitation behaviours, and the validity and reliability of this scale have been proven. In a study of anaesthesia early delirium in children by Bong et al.7 a score of ≥10 on the PAED scale was shown to have the greatest sensitivity and specificity for the diagnosis of anaesthesia early delirium.

The aim of this study was to investigate the effect on the occurrence of emergence delirium, and recovery, of propofol and ketofol in paediatric patients undergoing diagnostic MRI following premedication with intranasal dexmedetomidine and midazolam.

Conditions

  • Delirium
  • Pediatric Disorder
  • Anesthesia

Interventions

PROCEDURE

Outpatient Anesthesia

The inclusion criteria were children aged between 2 and 10 years, undergoing outpatient anaesthesia for elective MRI under sedation, and classified as American Society of Anesthesiologists (ASA) grade I-II. The study exclusion criteria were defined as difficult airway, allergies to the study drugs, asthma, severe central nervous system disease (eg, brain tumour, uncontrolled seizures), mental motor retardation, the application of another procedure after MRI sedation, and those whose parents declined to participate in the study.

Sponsors & Collaborators

  • Turkiye Yuksek Ihtisas Education and Research Hospital

    lead OTHER_GOV

Principal Investigators

  • Derya Karasu · Bursa Yuksek Ihtisas Training and Research Hospital

Eligibility

Min Age
2 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-01
Primary Completion
2018-11-01
Completion
2018-11-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04816344 on ClinicalTrials.gov